PRKClass II
Device Indicating An Exhalation Event
21 CFR 868.2375 / Anesthesiology
PRK is the FDA product code for Device Indicating An Exhalation Event, a class II device type, regulated under 21 CFR 868.2375. FDA's definition for this code reads: "To provide visual indication of each exhalation event". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PRK
- Device name
- Device Indicating An Exhalation Event
- FDA definition
- To provide visual indication of each exhalation event
- Regulation
- 21 CFR 868.2375
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code PRK
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2017 | 1 |
Applicants with the most clearances
Product code PRK| Applicant | Clearances |
|---|---|
| Tereopneuma | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code PRK.
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