SmartGuard technology; Predictive Low Glucose technology
FDA 510(k) clearance K251217 · decided 2025-08-29
Clearance details
- K-number
- K251217
- Device name
- SmartGuard technology; Predictive Low Glucose technology
- Applicant
- Medtronic Minimed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-04-21
- Decision date
- 2025-08-29
- Days to decision
- 130 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| SmartGuard Technology; Predictive Low Glucose Technology (K261962) | Medtronic MiniMed | 2026-07-09 |
| 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 |
| 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 |
|---|---|---|
| MiniMed 670G System (P160017/S133) | Medtronic Minimed, Inc. | 2025-12-18 |
| MiniMed 780G System (P160017/S125) | Medtronic Minimed, Inc. | 2025-12-11 |
| MiniMed 670G system MiniMed 770G system MiniMed 780G system (P160017/S131) | Medtronic Minimed, Inc. | 2025-12-10 |
| Simplera Sync Sensor; Guardian 4 Sensor (P250012/S005) | Medtronic Minimed, Inc. | 2025-12-10 |
| MiniMed 780G System (P160017/S134) | Medtronic Minimed, Inc. | 2025-12-08 |
| Simplera Sync Sensor (P250012/S007) | Medtronic Minimed, Inc. | 2025-12-08 |
| Simplera Sync Sensor (P250012/S006) | Medtronic Minimed, Inc. | 2025-12-05 |
| MiniMed 780G System (P160017/S132) | Medtronic Minimed, Inc. | 2025-12-05 |