FDA product code NQY: Ventilator, Continuous, Minimal Ventilatory Support, Home Use
NQY is the FDA product code for ventilator, continuous, minimal ventilatory support, home use. It is a Class II device, regulated under 21 CFR 868.5895 and reviewed by the Anesthesiology panel. Devices under NQY reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
This continuous ventilator, which operates using a fixed or passive exhaust port, is intended to treat patients with respiratory failure in the home.
Classification
| Field | Value |
|---|---|
| Device name | Ventilator, Continuous, Minimal Ventilatory Support, Home Use |
| Device class | Class II |
| Regulation | 21 CFR 868.5895 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Recalls for NQY devices
openFDA lists no recalls for product code NQY.
Frequently asked questions
What is FDA product code NQY?
NQY is the FDA product code for ventilator, continuous, minimal ventilatory support, home use. It is a Class II device, regulated under 21 CFR 868.5895 and reviewed by the Anesthesiology panel.
What device class is NQY?
Class II, regulation 21 CFR 868.5895. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NQY
- Run a recall and safety report across every NQY manufacturer
- Watch product code NQY 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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