FDA product code ONZ: Mechanical Ventilator
ONZ is the FDA product code for mechanical ventilator. It is a Class II device, regulated under 21 CFR 868.5895 and reviewed by the Anesthesiology panel. FDA has cleared 6 510(k) submissions under ONZ, from 3 different applicants. The average 510(k) review took 208 days (median 186).
Definition
This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregiver under the direction of a physician,
Classification
| Field | Value |
|---|---|
| Device name | Mechanical Ventilator |
| Device class | Class II |
| Regulation | 21 CFR 868.5895 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every ONZ clearance
Top ONZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Breathe Technologies, Inc. | 4 | 2011-02-11 |
| New Aera, Inc. | 1 | 2016-12-02 |
| Breathe Technologies | 1 | 2014-03-06 |
Most recent ONZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K152664 | New Aera, Inc. | TAV System | 2016-12-02 | 442 |
| K131562 | Breathe Technologies | BREATHE NIOV VENTILATION SYSTEM | 2014-03-06 | 280 |
| K103345 | Breathe Technologies, Inc. | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | 2011-02-11 | 88 |
| K102525 | Breathe Technologies, Inc. | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | 2010-12-02 | 91 |
| K100528 | Breathe Technologies, Inc. | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S | 2010-04-23 | 58 |
Recalls for ONZ devices
openFDA lists no recalls for product code ONZ.
Frequently asked questions
What is FDA product code ONZ?
ONZ is the FDA product code for mechanical ventilator. It is a Class II device, regulated under 21 CFR 868.5895 and reviewed by the Anesthesiology panel.
What device class is ONZ?
Class II, regulation 21 CFR 868.5895. Typical premarket route: 510(k).
How long does a 510(k) take for product code ONZ?
Across 6 cleared submissions the average was 208 days from receipt to decision (median 186).
Which companies have the most ONZ clearances?
Breathe Technologies, Inc. (4); New Aera, Inc. (1); Breathe Technologies (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ONZ
- Run a recall and safety report across every ONZ manufacturer
- Watch product code ONZ 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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