QOG — Injection Data Capture Device Class II
Classification Details
- Product Code
- QOG
- Device Class
- Class II
- Regulation Number
- 880.5860
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243901 | ypsomed | SmartPilot YpsoMate NS-A2.25 | August 28, 2025 |
| K251500 | biocorp production | MallyaG Injection Pen Adapter (MallyaG) | June 9, 2025 |
| K250555 | biocorp production | MallyaD injection pen adapter (MallyaD) | March 27, 2025 |
| K241803 | insulcloud s.l | INSULCLOCK® v2.0 PRO | August 22, 2024 |
| K231820 | biocorp production | SoloSmart Injection Pen Adapter (SoloSmart®) | January 12, 2024 |
| K222689 | biocorp production | Mallya Injection Pen Adapter (Mallya® for Solostar®) | December 5, 2022 |
| K212217 | eli lilly and | Tempo Smart Button | September 16, 2022 |