# K130664: Hyrdromax Hmef

- Pathway: 510(k) (Traditional)
- Applicant: A-M Systems
- Decided: Jun 21, 2013 after 101 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 K964204 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964204: Engstrom Hmef 1000, Datex Engstrom AB (1996) 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 and to add and retain moisture in the circuit as required. It is single patient use, disposable for patients with Tidal Volumes > 250 ml. Duration of use < 24 hours.

Source page: https://510kreport.com/device/K130664
Methodology: https://510kreport.com/methodology