FDA product code QOG: Injection Data Capture Device
QOG is the FDA product code for injection data capture device. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel. FDA has cleared 7 510(k) submissions under QOG, 7 in the last five years, from 4 different applicants. The average 510(k) review took 156 days (median 90); 118 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Injection Data Capture Device |
| Device class | Class II |
| Regulation | 21 CFR 880.5860 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for QOG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 2 | 258 |
| 2024 | 2 | 134 |
| 2025 | 3 | 102 |
Compare with all 510(k) review times · Search every QOG clearance
Top QOG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biocorp Production | 4 | 2025-06-09 |
| Ypsomed AG | 1 | 2025-08-28 |
| Insulcloud S.L. | 1 | 2024-08-22 |
| Eli Lilly and Company | 1 | 2022-09-16 |
Most recent QOG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243901 | Ypsomed AG | SmartPilot YpsoMate NS-A2.25 | 2025-08-28 | 252 |
| K251500 | Biocorp Production | MallyaG Injection Pen Adapter (MallyaG) | 2025-06-09 | 25 |
| K250555 | Biocorp Production | MallyaD injection pen adapter (MallyaD) | 2025-03-27 | 30 |
| K241803 | Insulcloud S.L. | INSULCLOCK® v2.0 PRO | 2024-08-22 | 62 |
| K231820 | Biocorp Production | SoloSmart Injection Pen Adapter (SoloSmart®) | 2024-01-12 | 205 |
Recalls for QOG devices
openFDA lists no recalls for product code QOG.
Frequently asked questions
What is FDA product code QOG?
QOG is the FDA product code for injection data capture device. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel.
What device class is QOG?
Class II, regulation 21 CFR 880.5860. Typical premarket route: 510(k).
How long does a 510(k) take for product code QOG?
Across 7 cleared submissions the average was 156 days from receipt to decision (median 90).
Which companies have the most QOG clearances?
Biocorp Production (4); Ypsomed AG (1); Insulcloud S.L. (1); Eli Lilly and Company (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QOG
- Run a recall and safety report across every QOG manufacturer
- Watch product code QOG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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