K243901 is an FDA 510(k) clearance for the SmartPilot YpsoMate NS-A2.25. This device is classified as a Injection Data Capture Device (Class II - Special Controls, product code QOG).
Submitted by Ypsomed AG (Burgdorf, CH). The FDA issued a Cleared decision on August 28, 2025, 252 days after receiving the submission on December 19, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860. An Injection Data Capture Device Is An Electrically-powered/electromechanical Accessory That Interfaces With Reusable Or Disposable Injection Devices For The Purposes Of Interpreting, Recording And Displaying And/or Transmitting Injection Data To A Connected Application Or Software..
| 510(k) Number | K243901 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2024 |
| Decision Date | August 28, 2025 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | QOG - Injection Data Capture Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
| Definition | An Injection Data Capture Device Is An Electrically-powered/electromechanical Accessory That Interfaces With Reusable Or Disposable Injection Devices For The Purposes Of Interpreting, Recording And Displaying And/or Transmitting Injection Data To A Connected Application Or Software. |