FDA product code QRX: Continuous Glucose Monitor Informed Insulin Dose Calculator
QRX is the FDA product code for continuous glucose monitor informed insulin dose calculator. It is a Class II device, regulated under 21 CFR 862.1358 and reviewed by the Clinical Chemistry panel. FDA has cleared 6 510(k) submissions under QRX, 6 in the last five years, from 4 different applicants. The average 510(k) review took 197 days (median 181); 159 days on average over the last three years. FDA has posted 2 recalls for QRX devices, 2 initiated in the last five years.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Continuous Glucose Monitor Informed Insulin Dose Calculator |
| Device class | Class II |
| Regulation | 21 CFR 862.1358 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for QRX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 2 | 212 |
| 2023 | 2 | 220 |
| 2025 | 1 | 75 |
| 2026 | 1 | 243 |
Compare with all 510(k) review times · Search every QRX clearance
Top QRX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Insulet Corporation | 3 | 2023-10-18 |
| DreaMed Diabetes, Ltd. | 1 | 2026-09-08 |
| Dexcom, Inc. | 1 | 2025-11-18 |
| Welldoc, Inc. | 1 | 2023-08-11 |
Most recent QRX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260062 | DreaMed Diabetes, Ltd. | MODI System | 2026-09-08 | 243 |
| K252818 | Dexcom, Inc. | Dexcom Smart Basal | 2025-11-18 | 75 |
| K231824 | Insulet Corporation | SmartBolus Calculator | 2023-10-18 | 119 |
| K222888 | Welldoc, Inc. | BlueStar CGM insulin dose calculator | 2023-08-11 | 322 |
| K222239 | Insulet Corporation | SmartBolus Calculator | 2022-08-19 | 24 |
Recalls for QRX devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-09-11.
| Year | Recalls |
|---|---|
| 2025 | 2 |
Frequently asked questions
What is FDA product code QRX?
QRX is the FDA product code for continuous glucose monitor informed insulin dose calculator. It is a Class II device, regulated under 21 CFR 862.1358 and reviewed by the Clinical Chemistry panel.
What device class is QRX?
Class II, regulation 21 CFR 862.1358. Typical premarket route: 510(k).
How long does a 510(k) take for product code QRX?
Across 6 cleared submissions the average was 197 days from receipt to decision (median 181).
Which companies have the most QRX clearances?
Insulet Corporation (3); DreaMed Diabetes, Ltd. (1); Dexcom, Inc. (1); Welldoc, Inc. (1).
Have QRX devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-09-11.
Next steps
- Run an FDA pathway report with predicate devices for product code QRX
- Run a recall and safety report across every QRX manufacturer
- Watch product code QRX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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