FDA product code QOS: Continuous Ventilator
QOS is the FDA product code for continuous ventilator. It is a Not classified device, reviewed by the Ear, Nose and Throat panel. Devices under QOS reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for QOS devices, 1 initiated in the last five years.
Definition
Intended to provide continuous ventilatory support for use during declared public health emergency. May be used in hospital or facility settings.
Classification
| Field | Value |
|---|---|
| Device name | Continuous Ventilator |
| Device class | Not classified |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QOS devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-08-19.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code QOS?
QOS is the FDA product code for continuous ventilator. It is a Not classified device, reviewed by the Ear, Nose and Throat panel.
What device class is QOS?
Not classified. Typical premarket route: PMA.
Have QOS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-08-19.
Next steps
- Run an FDA pathway report with predicate devices for product code QOS
- Run a recall and safety report across every QOS manufacturer
- Watch product code QOS 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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