QOGClass II
Injection Data Capture Device
21 CFR 880.5860 / General Hospital
QOG is the FDA product code for Injection Data Capture Device, a class II device type, regulated under 21 CFR 880.5860. FDA's definition for this code reads: "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". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QOG
- Device name
- Injection Data Capture Device
- 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.
- Regulation
- 21 CFR 880.5860
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 7
- Ingested recalls
- 0
Clearances, product code QOG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2022 | 2 |
| 2024 | 2 |
| 2025 | 3 |
Applicants with the most clearances
Product code QOG| Applicant | Clearances |
|---|---|
| Biocorp Production | 4 |
| Eli Lilly and Company, Pharmaceutical Delivery Systems | 1 |
| Insulcloud S.L. | 1 |
| Ypsomed AG | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.