QOG
7 FDA 510(k) clearances · Product code
90 daysmedian time to decision
427 days90th percentile
7clearances measured
FDA profile
- Official device name
- Injection Data Capture Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Medical specialty
- General Hospital
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SmartPilot YpsoMate NS-A2.25 (K243901) | Ypsomed AG | 2025-08-28 |
| MallyaG Injection Pen Adapter (MallyaG) (K251500) | Biocorp Production | 2025-06-09 |
| MallyaD injection pen adapter (MallyaD) (K250555) | Biocorp Production | 2025-03-27 |
| INSULCLOCK® v2.0 PRO (K241803) | Insulcloud S.L. | 2024-08-22 |
| SoloSmart Injection Pen Adapter (SoloSmart®) (K231820) | Biocorp Production | 2024-01-12 |
| Mallya Injection Pen Adapter (Mallya® for Solostar®) (K222689) | Biocorp Production | 2022-12-05 |
| Tempo Smart Button (K212217) | Eli Lilly and Company | 2022-09-16 |
Track QOG automatically
Every clearance here is in the API, with alerts when new ones post.