Submission Details
| 510(k) Number | K230483 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
Sep 2023
Decision
205d
Days
Class 2
Risk
About This 510(k) Submission
K230483 is an FDA 510(k) clearance for the Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15), 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 review panel. Regulated under 21 CFR 868.5260.
Device Classification
| Product Code | CAH — Filter, Bacterial, Breathing-circuit |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5260 |
Manufacturer
Similar Devices — CAH Filter, Bacterial, Breathing-circuit
All 199
K241339 · Besmed Health Business Corp
· Nov 2024
K222917 · Shaoxing Haitech Medical Products Co., Ltd.
· Feb 2024
K223258 · Intersurgical , Ltd.
· Jun 2023
K221472 · Ningbo Huakun Medical Equipment Co., Ltd.
· Feb 2023
K221836 · Dr?gerwerk AG & Co KGaA
· Dec 2022
K221250 · Ndd Medizintechnik AG
· Nov 2022
More from Passy-Muir, Inc.
View all
K990905
· JOH · Jun 1999
K970365
· JOH · Feb 1997
K962714
· JOH · Oct 1996
K944451
· JOH · Jul 1995