FDA product code PRK: Device Indicating An Exhalation Event
PRK is the FDA product code for device indicating an exhalation event. It is a Class II device, regulated under 21 CFR 868.2375 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under PRK. The average 510(k) review took 214 days (median 214).
Definition
To provide visual indication of each exhalation event
Classification
| Field | Value |
|---|---|
| Device name | Device Indicating An Exhalation Event |
| Device class | Class II |
| Regulation | 21 CFR 868.2375 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PRK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 214 |
Compare with all 510(k) review times · Search every PRK clearance
Top PRK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tereopneuma | 1 | 2017-02-17 |
Most recent PRK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K161953 | Tereopneuma | ReDe Mask | 2017-02-17 | 214 |
Recalls for PRK devices
openFDA lists no recalls for product code PRK.
Frequently asked questions
What is FDA product code PRK?
PRK is the FDA product code for device indicating an exhalation event. It is a Class II device, regulated under 21 CFR 868.2375 and reviewed by the Anesthesiology panel.
What device class is PRK?
Class II, regulation 21 CFR 868.2375. Typical premarket route: 510(k).
How long does a 510(k) take for product code PRK?
Across 1 cleared submissions the average was 214 days from receipt to decision (median 214).
Which companies have the most PRK clearances?
Tereopneuma (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PRK
- Run a recall and safety report across every PRK manufacturer
- Watch product code PRK 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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