# K013089: Ems Hepa Filter and Hme Combinations

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Medical Systems
- Decided: Mar 14, 2002 after 178 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 K941381 (1994). 6 ancestors in all.
39 later devices descend from it; 5 cite it directly.
8 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941676: Sterivent and Sterivent S, Mallinckrodt Medical (1994) Summary page 1.
- K941585: Hygroster, Mallinckrodt Medical (1994) Summary page 1.
- K941381: Hygrobac,S Hygroboy and Hygrobaby, Mallinckrodt Medical (1994) Summary page 1.
- K011212: Filterflo H, Arc Medical, Inc. (2001). Cleared while this submission was under review Summary page 1.
- K011132: Airlife Hepa Filter, Allegiance Healthcare Corp. (2001) Summary page 1.
- K002201: Electrostatic Hydrophobic Breathing Filter, Sims Portex, Inc. (2001) Summary page 1.

## Most influential descendants
- K033008: Air Safety Hepa and Non-Hepa Filters (2004), 29 descendants of its own
- K060705: Carina Home (2006), 22 descendants of its own
- K103167: Stellar 150 (2011), 20 descendants of its own
- K021265: Datex-Ohmeda Hmef 500 (2002), 11 descendants of its own
- K113053: Bipap a 30 Ventilatory Support System (2012), 8 descendants of its own

## 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 maintain and retain moisture for the exhaled breathe of the patient

Source page: https://510kreport.com/device/K013089
Methodology: https://510kreport.com/methodology