Lingo Glucose System
FDA 510(k) clearance K233655 · decided 2024-05-29
Clearance details
- K-number
- K233655
- Device name
- Lingo Glucose System
- Applicant
- Abbott
- Decision
- Substantially Equivalent
- Date received
- 2023-11-14
- Decision date
- 2024-05-29
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- SAF
- Device class
- 2
- Regulation number
- 862.1355
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Alameda, 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 |
| Signos Glucose Monitoring System (K250106) | Signos, Inc. | 2025-03-21 |
| 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 |
|---|---|---|
| CentriMag Circulatory Support System (P170038/S025) | Abbott | 2025-12-01 |
| CentriMag Circulatory Support System (P170038/S023) | Abbott | 2025-09-29 |
| CentriMag Circulatory Support System (P170038/S026) | Abbott | 2025-08-21 |
| CentriMag Circulatory Support System (P170038/S024) | Abbott | 2025-06-02 |
| CentriMag Circulatory Support System (P170038/S017) | Abbott | 2025-02-04 |
| CentriMag Circulatory Support System (P170038/S022) | Abbott | 2024-11-05 |
| CentriMag Circulatory Support System (P170038/S021) | Abbott | 2024-11-01 |
| CentriMag Circulatory Support System (P170038/S020) | Abbott | 2024-09-25 |