MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)
FDA 510(k) clearance K151236 · decided 2015-05-19
Clearance details
- K-number
- K151236
- Device name
- MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)
- Applicant
- Medtronic Minimed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-05-11
- Decision date
- 2015-05-19
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- PJT
- Device class
- 2
- Regulation number
- 862.1350
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Northridge, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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| 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 |