K223625 is an FDA 510(k) clearance for the CapnoSpot™ Pneumothorax Decompression Indicator. This device is classified as a Needle, Aspiration And Injection, Disposable (Class I - General Controls, product code GAA).
Submitted by Pneumeric, Inc. (Rochester, US). The FDA issued a Cleared decision on March 28, 2023, 113 days after receiving the submission on December 5, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K223625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2022 |
| Decision Date | March 28, 2023 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAA - Needle, Aspiration And Injection, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |