FDA product code SBH: Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
SBH is the FDA product code for integrated continuous glucose monitor for non-intensive glucose management, 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 3 510(k) submissions under SBH, 3 in the last five years, from 2 different applicants. The average 510(k) review took 98 days (median 84); 119 days on average over the last three years.
Definition
An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose management 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 across the range spanning clinically significant hypoglycemia and hyperglycemia levels in persons who are not on insulin and who do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose management 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.
Classification
| Field | Value |
|---|---|
| Device name | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, 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 SBH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 184 |
| 2026 | 2 | 54 |
Compare with all 510(k) review times · Search every SBH clearance
Top SBH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dexcom, Inc. | 2 | 2026-08-11 |
| Abbott Diabetes Care | 1 | 2024-06-07 |
Most recent SBH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262472 | Dexcom, Inc. | Stelo Glucose Biosensor System | 2026-08-11 | 25 |
| K260935 | Dexcom, Inc. | Stelo Glucose Biosensor System | 2026-06-12 | 84 |
| K233861 | Abbott Diabetes Care | Libre Rio Continuous Glucose Monitoring System | 2024-06-07 | 184 |
Recalls for SBH devices
openFDA lists no recalls for product code SBH.
Frequently asked questions
What is FDA product code SBH?
SBH is the FDA product code for integrated continuous glucose monitor for non-intensive glucose management, 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 SBH?
Class II, regulation 21 CFR 862.1355. Typical premarket route: 510(k).
How long does a 510(k) take for product code SBH?
Across 3 cleared submissions the average was 98 days from receipt to decision (median 84).
Which companies have the most SBH clearances?
Dexcom, Inc. (2); Abbott Diabetes Care (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SBH
- Run a recall and safety report across every SBH manufacturer
- Watch product code SBH 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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