SmartGuard Technology; Predictive Low Glucose Technology
FDA 510(k) clearance K261962 · decided 2026-07-09
Clearance details
- K-number
- K261962
- Device name
- SmartGuard Technology; Predictive Low Glucose Technology
- Applicant
- Medtronic MiniMed
- Decision
- Substantially Equivalent
- Date received
- 2026-06-11
- Decision date
- 2026-07-09
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- QJI
- Device class
- 2
- Regulation number
- 862.1356
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Northridge, 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 |
|---|---|---|
| Omnipod 6 algorithm (K261461) | Insulet Corporation | 2026-06-29 |
| Control-IQ+ technology (K260429) | Tandem Diabetes Care, Inc. | 2026-04-24 |
| SmartGuard Technology; Predictive Low Glucose Technology (K253701) | Medtronic Minimed | 2026-02-03 |
| SmartGuard technology; Predictive Low Glucose technology (K253585) | Medtronic Minimed, Inc. | 2026-01-14 |
| DBLG2 (K251152) | Diabeloop | 2025-12-19 |
| Omnipod 5 algorithm (K251779) | Insulet Corporation | 2025-12-03 |
| SmartGuard technology; Predictive Low Glucose technology (K251217) | Medtronic Minimed, Inc. | 2025-08-29 |
| Control-IQ+ technology (K250798) | Tandem Diabetes Care, Inc. | 2025-05-21 |
| Control-IQ+ technology (K243823) | Tandem Diabetes Care, Inc. | 2025-02-24 |
| SmartAdjust™ Technology (K241777) | Insulet Corporation | 2024-08-26 |
| SmartAdjust(TM) technology (K232741) | Insulet Corporation | 2024-05-29 |
| CamAPS FX (K232603) | Camdiab , Ltd. | 2024-05-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Simplera System (P160007/S059) | Medtronic Minimed | 2025-12-08 |
| Simplera System (P160007/S057) | Medtronic Minimed | 2025-12-05 |
| Medtronic MiniMed 630G System (P150001/S110) | Medtronic Minimed | 2025-10-16 |
| Guardian Connect System Simplera System (P160007/S056) | Medtronic Minimed | 2025-10-16 |
| Guardian Connect System (P160007/S054) | Medtronic Minimed | 2025-10-09 |
| Simplera System (P160007/S055) | Medtronic Minimed | 2025-09-12 |
| Guardian Connect system (P160007/S053) | Medtronic Minimed | 2025-08-25 |
| Simplera (TM) System (P160007/S052) | Medtronic Minimed | 2024-09-17 |