FDA product code QXY: Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature
QXY is the FDA product code for oscillometric-based, over-the-counter, atrial fibrillation notification feature. It is a Class II device, regulated under 21 CFR 870.1135 and reviewed by the Cardiovascular panel. Devices under QXY reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
An oscillometric-based, over-the-counter, atrial fibrillation notification feature is a software algorithm for analysis of signals from an oscillometric, non-invasive blood pressure measurement system to screen for possible atrial fibrillation in the device user.
Classification
| Field | Value |
|---|---|
| Device name | Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature |
| Device class | Class II |
| Regulation | 21 CFR 870.1135 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Recalls for QXY devices
openFDA lists no recalls for product code QXY.
Frequently asked questions
What is FDA product code QXY?
QXY is the FDA product code for oscillometric-based, over-the-counter, atrial fibrillation notification feature. It is a Class II device, regulated under 21 CFR 870.1135 and reviewed by the Cardiovascular panel.
What device class is QXY?
Class II, regulation 21 CFR 870.1135. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QXY
- Run a recall and safety report across every QXY manufacturer
- Watch product code QXY 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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