FDA product code OAZ: One-Way Air-Leak Valve
OAZ is the FDA product code for one-way air-leak valve. It is a HDE device, reviewed by the Anesthesiology panel. Devices under OAZ reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
To restrict air flow to the target section of the lung. To control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (lvrs). An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.
Classification
| Field | Value |
|---|---|
| Device name | One-Way Air-Leak Valve |
| Device class | HDE |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for OAZ devices
openFDA lists no recalls for product code OAZ.
Frequently asked questions
What is FDA product code OAZ?
OAZ is the FDA product code for one-way air-leak valve. It is a HDE device, reviewed by the Anesthesiology panel.
What device class is OAZ?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code OAZ
- Run a recall and safety report across every OAZ manufacturer
- Watch product code OAZ 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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