Stelo Glucose Biosensor System
FDA 510(k) clearance K261359 · decided 2026-05-21
Clearance details
- K-number
- K261359
- Device name
- Stelo Glucose Biosensor System
- Applicant
- Dexcom, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2026-04-24
- Decision date
- 2026-05-21
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- SAF
- Device class
- 2
- Regulation number
- 862.1355
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, 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 |
|---|---|---|
| Signos Glucose Monitoring System (K250106) | Signos, Inc. | 2025-03-21 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| G5 Mobile Continuous Glucose Monitoring System, G6 Continuous Glucose Monitoring System, G7 Continuous Glucose Monitorin (P120005/S091) | Dexcom, Inc. | 2024-01-09 |
| DEXCOM G5 Mobile Continuous Glucose Monitoring System (P120005/S090) | Dexcom, Inc. | 2023-01-12 |
| Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S088) | Dexcom, Inc. | 2022-01-20 |
| G5 Mobile Continuous Glucose Monitoring System (P120005/S089) | Dexcom, Inc. | 2021-12-21 |
| G5 Mobile Continuous Glucose Monitoring System (P120005/S087) | Dexcom, Inc. | 2020-09-03 |
| Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S086) | Dexcom, Inc. | 2020-01-08 |
| DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S083) | Dexcom, Inc. | 2019-11-01 |
| Dexcom G4 PLATINUM Continuous Glucose Monitoring System, Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S082) | Dexcom, Inc. | 2019-08-20 |