# K050927: RT019 Inspiratory/Expiratory Filter

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Aug 1, 2005 after 110 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: 1 generation back to K002839 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002839: End Expiratory Filter, Model RT020, Fisher & Paykel Healthcare, Ltd. (2001) Summary page 1.

## Most influential descendants
- K133666: RT016 Inspiratory Filter (2014), 0 descendants of its own

## Indications for use
The Fisher & Paykel Healthcare RT019 Inspiratory/Expiratory Filter is intended for use between a ventilator and a breathing circuit. Its function is to remove microbiological and particulate matter from gases entering and/or exiting a breathing circuit. The RT019 is intended to be connected to the ventilator inspiratory and/or expiratory ports. It is not directional in terms of flow and is a single use device.

Source page: https://510kreport.com/device/K050927
Methodology: https://510kreport.com/methodology