Data / Medical devices / Injection Data Capture Device
Injection Data Capture Device (QOG): 4 FDA-registered makers in 3 countries
4 establishments in 3 countries are registered with the FDA to make Injection Data Capture Device (product code QOG, Class 2, 21 CFR 880.5860). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on August 28, 2025, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- QOG
- Device class
- 2
- Regulation
- 880.5860
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| Switzerland | 2 |
| United States | 1 |
| Austria | 1 |
Makers of Injection Data Capture Device
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Eli Lilly and Company, Pharmaceutical Delivery Systems | Indianapolis, IN, United States | Manufacturer, Specification developer | 1 | September 16, 2022 | 0 | 0 | 0 | api.fda.gov |
| Ypsomed AG | BURGDORF Bern, Switzerland | Manufacturer | 1 | August 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ypsomed AG | Solothurn, Solothurn, Switzerland | Specification developer | 1 | August 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Flextronics International GMBH | ALTHOFEN Karnten, Austria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.