QOG
- Product code
- QOG
- Device name
- Injection Data Capture Device
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5860
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 7 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243901 | 2025-08-28 | Ypsomed AG | SmartPilot YpsoMate NS-A2.25 | |
| K251500 | 2025-06-09 | Biocorp Production | MallyaG Injection Pen Adapter (MallyaG) | |
| K250555 | 2025-03-27 | Biocorp Production | MallyaD injection pen adapter (MallyaD) | |
| K241803 | 2024-08-22 | Insulcloud S.L. | INSULCLOCK® v2.0 PRO | |
| K231820 | 2024-01-12 | Biocorp Production | SoloSmart Injection Pen Adapter (SoloSmart®) |
Official FDA classification page: QOG
Classification and pathway per current FDA publications. Data from openFDA (CC0).