# K032716: Portex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile and Non-Sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Portex, Ltd.
- Decided: Nov 28, 2003 after 87 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 K791307 (1979). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K791307: Unipor Breathing Circuit Filter, Pall Biomedical Products Co. (1979) Summary page 1.
- K964979: Porous Media DBF23 Disposable Respiratory Filter, Porous Media Corp. (1997) Summary page 1.

## Indications for use
The Portex Thermovent HEPA (High Efficiency Particulate) is a single use heat and moisture exchanging (HME) bacterial/viral breathing system filter with 'HEPA' grade filtration properties.

Source page: https://510kreport.com/device/K032716
Methodology: https://510kreport.com/methodology