510(k) K253701
- Device
- SmartGuard Technology; Predictive Low Glucose Technology
- Applicant
- Medtronic Minimed
- 510(k) number
- K253701
- Product code
- QJI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-03
- Date received
- 2025-11-24
- Regulation
- 862.1356
- Classification name
- Interoperable Automated Glycemic Controller
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Shivani Shah
- Address
- 18000 Devonshire St. Northridge CA US 91325 91325
FDA Registration Numbers
- 3007981285
- 2032227
- 3013756811
- 2246552
- 3015192982
- 3016798778
- 1220973
- 3016540876
- 3019004087
- 3008824097
- 3014585508
- 1220477
- 3026266833
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00199150002382 | MiniMed App | MEDTRONIC MINIMED, INC. | 2026-05-25 |
| 00199150002375 | MiniMed App | MEDTRONIC MINIMED, INC. | 2026-05-25 |
Other 510(k) Records For Product Code QJI
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260429 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2026-04-24 |
| K253585 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | 2026-01-14 |
| K251152 | DBLG2 | Diabeloop | 2025-12-19 |
| K251779 | Omnipod 5 algorithm | Insulet Corporation | 2025-12-03 |
| K251217 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | 2025-08-29 |
| K250798 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2025-05-21 |
| K243823 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2025-02-24 |
| K241777 | SmartAdjust Technology | Insulet Corporation | 2024-08-26 |
| K232741 | SmartAdjust(TM) technology | Insulet Corporation | 2024-05-29 |
| K232603 | CamAPS FX | Camdiab , Ltd. | 2024-05-23 |
| K234055 | DEKA Loop | Deka Research and Development | 2024-03-13 |
| K232382 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2023-11-03 |
| K232224 | iLet® Dosing Decision Software | Beta Bionics, Inc. | 2023-09-22 |
| K220916 | iLet® Dosing Decision Software | Beta Bionics, Inc. | 2023-05-19 |
| K203689 | Tidepool Loop | Tidepool Project | 2023-01-23 |