# K091185: 70530-Bactial/Viral Filter, 70531-Hmef, 70536-Bacterial/Viral Filter

- Pathway: 510(k) (Traditional)
- Applicant: Hsiner Co., Ltd.
- Decided: Jul 24, 2009 after 92 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 K792097 (1979). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961914: Bacteria/Viral Filter, Hudson Respiratory Care, Inc. (1996) Summary page 1.
- K964382: Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact Straight (19402), Gibeck, Inc. (1997) Summary page 1.

## Indications for use
Disposable single patient use bidirectional filters used to reduce the possible bacterial and/or viral cross contamination of ventilatory and anesthesia equipment associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. These devices are intended for use on all patient populations to filter respiratory gases where infection from airborne bacteria and viruses is a concern.

Source page: https://510kreport.com/device/K091185
Methodology: https://510kreport.com/methodology