K230483 is an FDA 510(k) clearance for the Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15). This device is classified as a Filter, Bacterial, Breathing-circuit (Class II - Special Controls, product code CAH).
Submitted by Passy-Muir, Inc. (Irvine, US). The FDA issued a Cleared decision on September 16, 2023, 205 days after receiving the submission on February 23, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K230483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2023 |
| Decision Date | September 16, 2023 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | CAH - Filter, Bacterial, Breathing-circuit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5260 |