FDA product code SAF: Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
SAF is the FDA product code for integrated continuous glucose monitor for non-intensive glucose monitoring, over-the-counter. It is a Class II device, regulated under 21 CFR 862.1355 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under SAF, 4 in the last five years, from 3 different applicants. The average 510(k) review took 91 days (median 70); 76 days on average over the last three years.
Definition
An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose monitoring is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels in persons who are not on insulin and do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose monitoring are designed to reliably and securely transmit glucose measurement data to digitally connected devices, excluding devices intended to control the delivery of insulin, and are intended to be used alone or in conjunction with these digitally connected medical devices. Device output should not be used to make treatment decisions without consulting with a qualified healthcare professional.
Classification
| Field | Value |
|---|---|
| Device name | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter |
| Device class | Class II |
| Regulation | 21 CFR 862.1355 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for SAF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 2 | 136 |
| 2025 | 1 | 65 |
| 2026 | 1 | 27 |
Compare with all 510(k) review times · Search every SAF clearance
Top SAF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dexcom, Inc. | 2 | 2026-05-21 |
| Signos, Inc. | 1 | 2025-03-21 |
| Abbott | 1 | 2024-05-29 |
Most recent SAF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261359 | Dexcom, Inc. | Stelo Glucose Biosensor System | 2026-05-21 | 27 |
| K250106 | Signos, Inc. | Signos Glucose Monitoring System | 2025-03-21 | 65 |
| K233655 | Abbott | Lingo Glucose System | 2024-05-29 | 197 |
| K234070 | Dexcom, Inc. | Stelo Glucose Biosensor System | 2024-03-05 | 74 |
Recalls for SAF devices
openFDA lists no recalls for product code SAF.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0423 — Intensive cardiac rehabilitation; with or without continuous ecg monitoring; without exercise, per session
- G0422 — Intensive cardiac rehabilitation; with or without continuous ecg monitoring with exercise, per session
Frequently asked questions
What is FDA product code SAF?
SAF is the FDA product code for integrated continuous glucose monitor for non-intensive glucose monitoring, over-the-counter. It is a Class II device, regulated under 21 CFR 862.1355 and reviewed by the Clinical Chemistry panel.
What device class is SAF?
Class II, regulation 21 CFR 862.1355. Typical premarket route: 510(k).
How long does a 510(k) take for product code SAF?
Across 4 cleared submissions the average was 91 days from receipt to decision (median 70).
Which companies have the most SAF clearances?
Dexcom, Inc. (2); Signos, Inc. (1); Abbott (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SAF
- Run a recall and safety report across every SAF manufacturer
- Watch product code SAF 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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