# K230483: Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)

- Pathway: 510(k) (Traditional)
- Applicant: Passy-Muir, Inc.
- Decided: Sep 16, 2023 after 205 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K941381 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192713: Altera Filter and HME/Filter, Meditera Tibbi Malzeme San VE Tic AS (2020) Summary page 4.

## Indications for use
For non-mechanically ventilated tracheostomy patients who are awake and alert or monitored by a trained healthcare provider or caregiver, where filtration of inspired and/or expired gases is desired. Use up to 24 hours. Environment of use – clinical settings including hospital, sub-acute, pre-hospital, and home. For adults with Tidal Volumes >300 ml and pediatrics with Tidal Volumes >80 ml. Do not use on neonate or infant patients.

Source page: https://510kreport.com/device/K230483
Methodology: https://510kreport.com/methodology