# K252643: Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical Sdn. Bhd.
- Decided: May 15, 2026 after 267 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 K964382 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965016: Iso-Gard Filter Angled (18212)/Iso-Gard Filter Straight (19212), Gibeck, Inc. (1997) Summary page 5.
- K964382: Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact Straight (19402), Gibeck, Inc. (1997) Summary page 5.

## Indications for use
Iso-Gard Filter Straight: The device is intended to remove microbiological and particulate matter from the gases in the breathing circuit. Humid-Vent Filter Compact Angled: The device is a combined Heat and Moisture Exchanger (HME) and Bacterial/Viral Filter for humidification and bacterial/viral filtration during anesthesia and ventilator care.

Source page: https://510kreport.com/device/K252643
Methodology: https://510kreport.com/methodology