UpDoc
FDA 510(k) clearance K253281 · decided 2025-12-23
Clearance details
- K-number
- K253281
- Device name
- UpDoc
- Applicant
- Updoc, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-29
- Decision date
- 2025-12-23
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- NDC
- Device class
- 2
- Regulation number
- 868.1890
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mountain View, 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 |
|---|---|---|
| Glucommander (K254102) | Glytec, LLC | 2026-05-27 |
| EndoTool IV Cloud 1.0 (K260910) | Glooko, Inc. | 2026-05-01 |
| MiniMed Go App (K253512) | Medtronic Minimed | 2026-01-08 |
| T1D1 (K252104) | Comerge AG | 2025-08-20 |
| EndoTool IV (3.1) (K241088) | Monarch Medical Technologies | 2024-12-11 |
| InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (K242775) | Medtronic Minimed | 2024-11-12 |
| iSage Rx (K242066) | Amalgam Rx, Inc. | 2024-08-21 |
| Insulia Bolus Companion (K232451) | Voluntis Sa. | 2023-12-12 |
| BlueStar and BlueStar Rx (K230813) | Welldoc, Inc. | 2023-07-28 |
| Digital Routines (K221924) | Gnc Holdings, LLC | 2023-03-15 |
| EndoTool SubQ 2.1 (K211160) | Monarch Medical Technologies, LLC | 2021-10-28 |
| BlueStar Rx (K203434) | Welldoc, Inc. | 2021-09-08 |
Recalls involving this device
No recalls on record reference this clearance.