Lubricant, Personal (NUC) — FDA decisions, comparisons and evidence
The 2021–2025 analysis contains 64 selected substantially-equivalent FDA decisions under primary product code NUC. Use it to compare documented submissions and evidence with your product. A separate 2026 update contains 12 decisions through 2026-09-27. The latest selected decision across the acquired endpoint is dated 2026-09-23. Neither set establishes a suitable predicate or the route for your device. The complete-year window has 64 decisions; the separate all-observed-date count is 249. 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?
This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.
Compare the proposed indication, user, anatomy, technology and operating principle with this actual scope; record differences and unresolved facts.
§ 884.5300 Condom. (a) Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility. (b) Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic. (2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document. [73 FR 66538, Nov. 10, 2008]
Read the identification, classification, conditions and referenced limitations in the cited section. A numeric reference match is not a buyer classification or exemption determination.
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.
64Selected decisions in these five years
147.0Median receipt-to-decision calendar days
64Valid date pairs in the distribution
The middle 50% of the 64 valid date pairs spans 91.8–244.5 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.
202120
202214
202313
20246
202511
Compare like submission types
Recorded type
Decisions
Valid date pairs
Median calendar days
Middle 50%
Abbreviated
1
1
Withheld: n < 20
—
Traditional
63
63
143.0
91.5–239.5
Different submission types and evidence packages are not interchangeable. These selected records do not establish that a particular route is available for your product.
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.
249 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
12 selected decisions from 2026-01-01 to 2026-09-27. The equivalent previous-year period contains 8 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.
K261292 ↗PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)
PR Personal Care Laboratories
2026-06-11
Traditional
52
K252914 ↗Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
Hathor Professional Skincare , Ltd.
2026-06-09
Traditional
270
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.
This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms. [1]
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 NUC 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.
