# K954828: Iso-Gard Hepa Filter-Hme, Iso-Ard Hepa Filter-Hme W/Port

- Pathway: 510(k) (Traditional)
- Applicant: Gibeck, Inc.
- Decided: May 2, 1996 after 195 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) Humid-Vent Filter: named in the summary without a submission number

Source page: https://510kreport.com/device/K954828
Methodology: https://510kreport.com/methodology