FDA record research

Multiple Use Blood Lancet For Single Patient Use Only (QRL) — FDA decisions, comparisons and evidence

The 2021–2025 analysis contains 24 selected substantially-equivalent FDA decisions under primary product code QRL. Use it to compare documented submissions and evidence with your product. A separate 2026 update contains 3 decisions through 2026-09-27. The latest selected decision across the acquired endpoint is dated 2026-08-18. Neither set establishes a suitable predicate or the route for your device. The complete-year window has 24 decisions; the separate all-observed-date count is 27. These denominators describe different date ranges.

Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.

Recorded scope and its declared regulatory reference

An exact FDA-record regulation_number match to one acquired Title 21 section. Records with the same normalized scope definition, class, regulation and recorded submission/GMP flags are grouped. Sparse definitions and generic exemption boilerplate do not qualify. No text-similarity equivalence or legal applicability is inferred.

What scope does the FDA record describe?

A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Compare the proposed indication, user, anatomy, technology and operating principle with this actual scope; record differences and unresolved facts.

Cited source

Which current section does the record cite?

§ 878.4850 Blood lancets. (a) Single use only blood lancet with an integral sharps injury prevention feature —(1) Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use. (2) Classification. Class II (special controls). The special controls are: (i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( e.g., blade). (v) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature. (B) Handwashing instructions for the user before and after use of the device. (C) Instructions on preparation ( e.g., cleaning, disinfection) of the skin to be pierced. (D) Instructions for the safe disposal of the device. (E) Labeling must be appropriate for the intended use environment. ( 1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves. ( 2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users. (vi) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Discard the entire device after use.” (B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.” (b) Single use only blood lancet without an integral sharps injury prevention feature —(1) Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. (2) Classification. Class II (special controls). The special controls are: (i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( e.g., blade). (v) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device. (B) Handwashing instructions for the user before and after use of the device. (C) Instructions on preparation ( e.g., cleaning, disinfection) of the skin to be pierced. (D) Instructions for the safe disposal of the device. (E) Labeling must be appropriate for the intended use environment. ( 1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves. ( 2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users. (vi) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Discard the entire device after use.” (B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.” (c) Multiple use blood lancet for single patient use only —(1) Identification. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. (2) Classification. Class II (special controls). The special controls are: (i) The design characteristics of the device must ensure that: (A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and (B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( e.g., blade). (v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected. (vi) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device. (B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use. (C) Handwashing instructions for the user before and after use of the device. (D) Instructions on preparation ( e.g., cleaning, disinfection) of the skin to be pierced. (E) Instructions on the cleaning and disinfection of the device. (F) Instructions for the safe disposal of the device. (G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades. (H) Labeling must be appropriate for the intended use environment. ( 1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves. ( 2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users. (vii) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.” (B) “Used lancet blades must be safely discarded after a single use.” (C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.” (d) Multiple use blood lancet for multiple patient use —(1) Identification. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. (2) Classification. Class III (premarket approval). (3) Date PMA or notice of completion of a PDP is required: A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. [86 FR 66188, Nov. 22, 2021, as amended at 86 FR 66179, Nov. 22, 2021]

Read the identification, classification, conditions and referenced limitations in the cited section. A numeric reference match is not a buyer classification or exemption determination.

Cited source

Historical FDA comparison

2021–2025: five complete calendar years

Primary code QRL

All statistics in this section use decisions dated 2021-01-01 to 2025-12-31. The partial 2026 update below is excluded from these distributions.

24Selected decisions in these five years

89.5Median receipt-to-decision calendar days

24Valid date pairs in the distribution

The middle 50% of the 24 valid date pairs spans 58.0–142.2 calendar days. This describes selected recorded submissions, including elapsed time outside active FDA review. It is not an FDA review-time measure or a delivery promise.

20210

202217

20233

20242

20252

Compare like submission types

Recorded type	Decisions	Valid date pairs	Median calendar days	Middle 50%
Special	2	2	Withheld: n < 20	—
Traditional	22	22	98.5	63.5–150.8

Different submission types and evidence packages are not interchangeable. These selected records do not establish that a particular route is available for your product.

Statistical source: FDA openFDA 510(k) decision dataset. Partition 1 Download the identified records and dates (CSV).

Filters, exclusions and reproducible calculation

Deduplicate by official submission ID across the complete current manifest partitions. Select exact primary product code, K-number format and the stated SE decision codes with valid dates. Recent distributions use the five complete calendar years preceding the latest valid endpoint decision year. Partial-year counts compare equal January-to-cutoff periods. Quartiles use linear interpolation at (n-1)*p and are withheld below 20 valid date pairs. The analysis n describes only its declared complete-year window; selected_se_n separately counts all selected recorded dates through the cutoff.

27 selected records across all observed dates; 0 other/invalid identifier or decision-date records excluded. 0 missing or invalid date pairs in the five-year window.

Date fields: date_received → decision_date. Quantiles: Hyndman–Fan type 7: linear interpolation at (n − 1) × p; displayed to one decimal; n ≥ 20 valid pairs.

Receipt-to-decision calendar elapsed time includes time outside active FDA review; it is not FDA review time, a promised project timeline or an estimate of future clearance. This selected recorded cohort does not include all applications or establish a success probability, predicate suitability, market size, current market availability or legal authorization for another product.

Calculation fda-buyer-research-3 · database cutoff 2026-09-27. CSV rows identify each official K-number, cohort, date pair, exclusion reason and source version.

Separate partial-year update

2026 decisions through 2026-09-27

3 selected decisions from 2026-01-01 to 2026-09-27. The equivalent previous-year period contains 1 decisions through 2025-09-27. These counts describe the records; they are not market growth or submission success rates.

Named records to investigate

Latest decisions across the database

These dated records may come from 2026 or earlier years. They are a separate investigation list, not the five-year statistical cohort. Compare the actual indications and technology before considering a record as a comparator.

Official record / device	Recorded applicant	Decision	Recorded type	Calendar days
K262135 ↗Lancing device	Tianjin Huahong Technology Co., Ltd.	2026-08-18	Traditional	54
K262211 ↗Lancet	Tianjin Huahong Technology Co., Ltd.	2026-07-22	Special	22
K260122 ↗Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)	SteriLance Medical (Suzhou), Inc.	2026-07-06	Traditional	172
K253706 ↗Lancing device (HH-XV-T)	Tianjin Huahong Technology Co., Ltd.	2025-12-09	Special	15
K250813 ↗MICROLET®NEXT 2 Lancing Device	Ascensia Diabetes Care U.S., Inc.	2025-05-14	Traditional	58
K243306 ↗Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)	Tianjin Huahong Technology Co., Ltd.	2024-11-15	Special	25
K232912 ↗Facet Aurora Reusable Lancet Base	Facet Technologies, LLC	2024-01-25	Traditional	128
K231797 ↗Medifun Lancing Device, Model No. LD-E1	Medifun Corporation	2023-11-22	Traditional	155

Supporting documents actually acquired

Go beyond the database row

Read the source context, then compare the evidence with your design. Topic locations below are text matches, including possible limitations or negative statements; they are not a mandatory test list.

K262135 · official summary PDF ↗

Term mention: Performance testing · PDF page 10 Term occurrence only; read the original passage, including limitations and negation.

K262211 · official summary PDF ↗

Term mention: Shelf life · PDF page 6 Term occurrence only; read the original passage, including limitations and negation.
Term mention: Sterilization · PDF page 7 Term occurrence only; read the original passage, including limitations and negation.
Term mention: Biocompatibility · PDF page 9 Term occurrence only; read the original passage, including limitations and negation.
Term mention: Performance testing · PDF page 11 Term occurrence only; read the original passage, including limitations and negation.

K260122 · official summary PDF ↗

Term mention: Biocompatibility · PDF page 7 Term occurrence only; read the original passage, including limitations and negation.
Term mention: Performance testing · PDF page 8 Term occurrence only; read the original passage, including limitations and negation.

The documents are a bounded sample of acquired summaries, not complete evidence coverage of the cohort.

Recorded classification context

Known context: US. Match the intended use and design with the recorded category before treating it as applicable.

Source fact	Recorded value
FDA product code	QRL [1]
Generic device category	Multiple Use Blood Lancet For Single Patient Use Only [1]
Recorded scope	A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. [1]
Recorded class	2 [1]
Regulation	878.4850 [1]
Medical specialty	General, Plastic Surgery [1]

Build a comparison that explains the differences

Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.

Which specific part of the recorded scope fits or differs?
Put your proposed label and design beside the quoted definition. Record matching facts, differences and missing facts separately; naming the category alone cannot resolve scope.
Useful evidence: Proposed indication/design and a definition-to-product comparison with source locators.
Have the cited section and its limitations been reviewed?
Record the applicable paragraph, conditions and cross-referenced limitations after specialist review. Keep a claimed exemption separate from actual establishment, listing and quality-system responsibilities.
Useful evidence: Dated classification/route rationale and the current provisions relied on, with unresolved conditions.
Compare your intended use with a named decision
Choose a named record above. Put your proposed claim beside its actual indications-for-use statement. Record different patients, users, anatomy, settings and output claims; do not treat a shared code as proof of equivalence.
Useful evidence: Your draft indications for use + the selected official summary and its exact page.
Explain the technology and evidence differences
For each comparison, record the different materials, hardware, software functions and operating conditions. Link each difference to existing evidence or an unresolved evaluation task.
Useful evidence: A three-column matrix: comparator fact / your design fact / evidence or unresolved gap.
Make the estimate comparable
Use the 2021–2025 cohort, and compare the recorded submission type before discussing calendar elapsed time. Separate your own preparation work from the recorded receipt-to-decision period.
Useful evidence: Chosen K numbers, submission types, dates and your own document/test readiness.

Work packages and dependencies

Conditional: FDA 510(k) Submission Services — Review the supplied facts and evidence gaps before confirming the service scope.
Optional: Find FDA US Agent Services | Compare & Get Quotes — Include only if your product, actor and delivery needs justify this additional scope. Confirm the responsibility and evidence handoff with the coordinating specialist.
Optional: FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment) — Include only if your product, actor and delivery needs justify this additional scope. Confirm the responsibility and evidence handoff with the coordinating specialist.

What needs to happen first

FDA 510(k) Submission Services → Find FDA US Agent Services | Compare & Get Quotes: Confirm the main product/actor scope and evidence gaps before deciding whether to commission this additional service.
FDA 510(k) Submission Services → FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment): Confirm the main product/actor scope and evidence gaps before deciding whether to commission this additional service.

Questions for providers

Which of the named QRL decisions are actually comparable to our proposed indications and technology, and which would you exclude?
Which evidence differences prevent us from using the comparison yet, and what deliverable resolves each one?
Does your schedule separate submission preparation, testing, FDA interactions and customer response time? What assumptions change it?

Sources and data dates

Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.