FDA product code OQX: Self-Contained Blood Grouping
OQX is the FDA product code for self-contained blood grouping. It is a Class II device, regulated under 21 CFR 864.9175 and reviewed by the Hematology panel. Devices under OQX reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for OQX devices, 1 initiated in the last five years.
Definition
Intended for single use for individual blood group determination for educational and informational purposes
Classification
| Field | Value |
|---|---|
| Device name | Self-Contained Blood Grouping |
| Device class | Class II |
| Regulation | 21 CFR 864.9175 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for OQX devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code OQX?
OQX is the FDA product code for self-contained blood grouping. It is a Class II device, regulated under 21 CFR 864.9175 and reviewed by the Hematology panel.
What device class is OQX?
Class II, regulation 21 CFR 864.9175. Typical premarket route: 510(k).
Have OQX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code OQX
- Run a recall and safety report across every OQX manufacturer
- Watch product code OQX 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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