Cruxi
FDA record research
The 2021–2025 analysis contains 5 selected substantially-equivalent FDA decisions under primary product code QRX. Use it to compare documented submissions and evidence with your product. A separate 2026 update contains 1 decisions through 2026-09-27. The latest selected decision across the acquired endpoint is dated 2026-09-08. Neither set establishes a suitable predicate or the route for your device. The complete-year window has 5 decisions; the separate all-observed-date count is 6. These denominators describe different date ranges.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
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.
A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information.
Compare the proposed indication, user, anatomy, technology and operating principle with this actual scope; record differences and unresolved facts.
§ 862.1358 Insulin therapy adjustment device. (a) Identification. An insulin therapy adjustment device is a device intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens for patients with diabetes mellitus. (b) Classification. Class II (special controls). The special controls for this device are: (1) Design verification and validation must include the following: (i) A complete description of the required data inputs, including timeframe over which data inputs must be collected and number of data points required for accurate recommendations; (ii) A complete description of the types of device outputs and insulin therapy adjustment recommendations, including how the recommendations are generated; (iii) Robust data demonstrating the clinical validity of the device outputs and insulin therapy recommendations; (iv) A robust assessment of all input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs, to ensure accurate and reliable therapy adjustment recommendations. This assessment must include adequate clinical justification for each specification; (v) A detailed strategy to ensure secure and reliable means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures; (vi) Robust data demonstrating that users can understand and appropriately interpret recommendations generated by the device; and (vii) An appropriate mitigation strategy to minimize the occurrence of dosing recommendation errors, and to mitigate the risk to patients of any residual dosing recommendation errors to a clinically acceptable level. (2) The device must not be intended for use in implementing automated insulin dosing. (3) Your 21 CFR 809.10(b) labeling must include: (i) The identification of specific insulin formulations that have been demonstrated to be compatible with use of the device; (ii) A detailed description of the specifications of compatible devices that provide acceptable input data (e.g., continuous glucose monitors, insulin pumps) used to provide accurate and reliable therapy adjustment recommendations; (iii) A detailed description of all types of required data (inputs) and dosing recommendations (outputs) that are provided by the device; and (iv) A description of device limitations, and instructions to prevent possible disruption of accurate therapy adjustment recommendations (e.g., time zone changes due to travel). [83 FR 54874, Nov. 1, 2018]
Read the identification, classification, conditions and referenced limitations in the cited section. A numeric reference match is not a buyer classification or exemption determination.
Historical FDA comparison
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.
There are 5 valid recent date pairs. Distribution summaries require at least 20; older records are not substituted for a current benchmark.
Statistical source: FDA openFDA 510(k) decision dataset. Partition 1 Download the identified records and dates (CSV).
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.
6 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
1 selected decisions from 2026-01-01 to 2026-09-27. The equivalent previous-year period contains 0 decisions through 2025-09-27. These counts describe the records; they are not market growth or submission success rates.
Named records to investigate
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 |
|---|---|---|---|---|
| K260062 ↗MODI System | DreaMed Diabetes, Ltd. | 2026-09-08 | Traditional | 243 |
| K252818 ↗Dexcom Smart Basal | Dexcom, Inc. | 2025-11-18 | Traditional | 75 |
| K231824 ↗SmartBolus Calculator | Insulet Corporation | 2023-10-18 | Traditional | 119 |
| K222888 ↗BlueStar CGM insulin dose calculator | Welldoc, Inc. | 2023-08-11 | Traditional | 322 |
| K222239 ↗SmartBolus Calculator | Insulet Corporation | 2022-08-19 | Traditional | 24 |
| K203772 ↗Omnipod 5 SmartBolus Calculator | Insulet Corporation | 2022-01-27 | Traditional | 400 |
Supporting documents actually acquired
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.
The documents are a bounded sample of acquired summaries, not complete evidence coverage of the cohort.
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 | QRX [1] |
| Generic device category | Continuous Glucose Monitor Informed Insulin Dose Calculator [1] |
| Recorded scope | A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information. [1] |
| Recorded class | 2 [1] |
| Regulation | 862.1358 [1] |
| Medical specialty | Clinical Chemistry [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.
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.
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.
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.
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.
This recent cohort has fewer than 20 valid date pairs, so it supplies no median or percentile benchmark. Ask for a schedule based on actual preparation, evidence gaps, interactions and response assumptions; keep any historical decision context separately dated.
Useful evidence: Document/test readiness, unresolved route/evidence tasks and the assumptions behind the specialist’s proposed sequence.
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 936de5f5d47b9293b702fc32512a79173969fb788c74a63d9b91abe73f3b86a5
Fri, 02 Oct 2026 17:03:01 GMT · retrieved 2026-10-06
Source key D02 · snapshot b9bfca28761fd1d44fdeb79f3b5ce80aa87d615985da0f56130b2f1710dce438
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002
Fri, 05 Dec 2025 21:03:51 GMT · retrieved 2026-10-07
Source key D02 · snapshot 4b3dd2fa31d021354346afd4854eb4a86c8c0591f34927773b08f54c15cab7f1
Thu, 19 Oct 2023 13:53:06 GMT · retrieved 2026-10-07
Source key D02 · snapshot 9a25626f3ff7ed5c956c755be6e381e1f80254999003a512c430ee059d6f48b5
Thu, 01 Oct 2026 22:01:48 GMT · retrieved 2026-10-06
Source key D04 · snapshot 2fb992918a3879de132b47a33c856da2b3234ee3d96cfd79fab03acf30512496
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