FDA product code SFU: Glucose Range Monitoring System
SFU is the FDA product code for glucose range monitoring system. It is a Class II device, regulated under 21 CFR 862.1359 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under SFU, 1 in the last five years. The average 510(k) review took 53 days (median 53); 53 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A glucose range monitoring system (GRM) is intended to automatically measure glucose in the body and provide qualitative or semi-quantitative information about glucose levels or trends continuously or frequently. GRM systems are intended to support general user awareness of glucose ranges related to glycemic control. Outputs from GRM systems do not represent quantitative glucose concentration values and GRM systems are not intended to be used for acute medical decision-making, such as insulin dosing or medication adjustment.
Classification
| Field | Value |
|---|---|
| Device name | Glucose Range Monitoring System |
| Device class | Class II |
| Regulation | 21 CFR 862.1359 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for SFU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 53 |
Compare with all 510(k) review times · Search every SFU clearance
Top SFU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biolinq Incorporated | 1 | 2026-09-18 |
Most recent SFU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262599 | Biolinq Incorporated | Biolinq Shine Autonomous Time-in-Range Microsensor | 2026-09-18 | 53 |
Recalls for SFU devices
openFDA lists no recalls for product code SFU.
Frequently asked questions
What is FDA product code SFU?
SFU is the FDA product code for glucose range monitoring system. It is a Class II device, regulated under 21 CFR 862.1359 and reviewed by the Clinical Chemistry panel.
What device class is SFU?
Class II, regulation 21 CFR 862.1359. Typical premarket route: 510(k).
How long does a 510(k) take for product code SFU?
Across 1 cleared submissions the average was 53 days from receipt to decision (median 53).
Which companies have the most SFU clearances?
Biolinq Incorporated (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SFU
- Run a recall and safety report across every SFU manufacturer
- Watch product code SFU 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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