Signos Glucose Monitoring System
FDA 510(k) clearance K250106 · decided 2025-03-21
Clearance details
- K-number
- K250106
- Device name
- Signos Glucose Monitoring System
- Applicant
- Signos, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-01-15
- Decision date
- 2025-03-21
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- SAF
- Device class
- 2
- Regulation number
- 862.1355
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Laguna Niguel, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Stelo Glucose Biosensor System (K261359) | Dexcom, Inc. | 2026-05-21 |
| Lingo Glucose System (K233655) | Abbott | 2024-05-29 |
| Stelo Glucose Biosensor System (K234070) | Dexcom, Inc. | 2024-03-05 |
Recalls involving this device
No recalls on record reference this clearance.