# K012958: Breathing Circuit Filter

- Pathway: 510(k) (Traditional)
- Applicant: Emergency Filtration Products, Inc.
- Decided: Feb 22, 2002 after 171 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SIMS Portex, Inc. Breathing Filter: named in the summary without a submission number
- (no number) SIMS Portex, Inc. Filtered HME: named in the summary without a submission number

## Indications for use
Heat and passive humidification with filtration between patient and circuit. Designed for use with ventilators, anesthesia machines, and open flow systems where filtration of inspired or expired gases is required such as in hospitals, surgical centers, long term health care facilities and institutions utilizing anesthesiology or respiratory equipment. Place at machine end on the inspiratory and/or expiratory side of the patient circuit. Single patient use. For prescription use only. For sale by or on the order of a physician.

Source page: https://510kreport.com/device/K012958
Methodology: https://510kreport.com/methodology