# K112958: Humid-Vent Hepa

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical
- Decided: Sep 21, 2012 after 352 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) Teleflex Medical's Gibeck Iso-Gard Angled and Straight Filters: named in the summary without a submission number
- (no number) Teleflex Medical's Gibeck Humid-Vent 2HME: named in the summary without a submission number
- (no number) Covidien's Hygroster Filter / HME combination bacterial / viral filter (HEPA) aid heat / moisture exchanger (HME): named in the summary without a submission number

## Indications for use
The Humid-Vent HEPA Filters are used for humidification and bacterial/viral filtration during anesthesia and ventilator care.

Source page: https://510kreport.com/device/K112958
Methodology: https://510kreport.com/methodology