# K133666: RT016 Inspiratory Filter

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Feb 5, 2014 after 68 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: 2 generations back to K002839 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050927: RT019 Inspiratory/Expiratory Filter, Fisher & Paykel Healthcare, Ltd. (2005) Summary page 1.

## Indications for use
The Fisher & Paykel Healthcare RT016 Inspiratory Filter is intended for use between a ventilator and breathing circuit. Its function is to remove microbiological and particulate matter from gases entering a breathing circuit. The RT016 is intended to be connected to the ventilator inspiratory port. It is not directional in terms of flow and is a single use device.

Source page: https://510kreport.com/device/K133666
Methodology: https://510kreport.com/methodology