510(k) K243901
- Device
- SmartPilot YpsoMate NS-A2.25
- Applicant
- Ypsomed AG
- 510(k) number
- K243901
- Product code
- QOG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-28
- Date received
- 2024-12-19
- Regulation
- 880.5860
- Classification name
- Injection Data Capture Device
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Johannes Schmid
- Address
- Brunnmattstrasse 6 Burgdorf CH 3401 3401
FDA Registration Numbers#
- 3002806818
- 3005170966
- 1819470
- 3006126537
- 3016525500
- 2954323
- 3006371704
Source Documents#
Other 510(k) Records For Product Code QOG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251500 | MallyaG Injection Pen Adapter (MallyaG) | Biocorp Production | 2025-06-09 |
| K250555 | MallyaD injection pen adapter (MallyaD) | Biocorp Production | 2025-03-27 |
| K241803 | INSULCLOCK® v2.0 PRO | Insulcloud S.L. | 2024-08-22 |
| K231820 | SoloSmart Injection Pen Adapter (SoloSmart®) | Biocorp Production | 2024-01-12 |
| K222689 | Mallya Injection Pen Adapter (Mallya® for Solostar®) | Biocorp Production | 2022-12-05 |
| K212217 | Tempo Smart Button | Eli Lilly and Company | 2022-09-16 |