# K014281: Gard Filter, Combigard Filte / Hme

- Pathway: 510(k) (Traditional)
- Applicant: Munktell Filter AB
- Decided: Jun 26, 2002 after 181 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 K941676 (1994). 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)
- K941676: Sterivent and Sterivent S, Mallinckrodt Medical (1994) Summary page 1.
- K011212: Filterflo H, Arc Medical, Inc. (2001)
- K964979: Porous Media DBF23 Disposable Respiratory Filter, Porous Media Corp. (1997) Summary page 1.

## Indications for use
For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired. To be placed at the machine-side of the circuit only. Single patient use. Duration of use up to 24 hours.

Source page: https://510kreport.com/device/K014281
Methodology: https://510kreport.com/methodology