# K151498: Breathing circuit bacterial/viral filter

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Haisheng Medical Device Co., Ltd.
- Decided: Dec 18, 2015 after 197 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 K941381 (1994). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013122: Ems Electrostatic Fliter and Hme Combination, Engineered Medical Systems (2002) Summary page 4.

## Most influential descendants
- K192713: Altera Filter and HME/Filter (2020), 1 descendant of its own
- K230483: Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) (2023), 0 descendants of its own

## Indications for use
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to add, maintain, retain moisture for the exhaled breathe of the patient. Use up to 24 hours. The Models of the filters are A501-1, A501-2, A501-3, and A501-4. The filters are intended for patient population that weighs greater than 10Kgs.

Source page: https://510kreport.com/device/K151498
Methodology: https://510kreport.com/methodology