InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
FDA 510(k) clearance K242775 · decided 2024-11-12
Clearance details
- K-number
- K242775
- Device name
- InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
- Applicant
- Medtronic Minimed
- Decision
- Substantially Equivalent
- Date received
- 2024-09-13
- Decision date
- 2024-11-12
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- NDC
- Device class
- 2
- Regulation number
- 868.1890
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Northridge, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| InPen App, Model/CFN Number: MMT-8061 (Android Users) recall (Z-0958-2026) | Medtronic MiniMed, Inc. | 2025-12-18 |
| InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) recall (Z-2496-2025) | Medtronic MiniMed, Inc. | 2025-09-02 |
| InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, recall (Z-1650-2025) | Medtronic MiniMed, Inc. | 2025-04-21 |
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 |