# K013122: Ems Electrostatic Fliter and Hme Combination

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Medical Systems
- Decided: Apr 19, 2002 after 212 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). 3 ancestors in all.
33 later devices descend from it; 2 cite it directly.
8 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941536: Barrierbac and Barrierbac S, Mallinckrodt Medical (1994) Summary page 1.
- K941381: Hygrobac,S Hygroboy and Hygrobaby, Mallinckrodt Medical (1994) 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
- K113053: Bipap a 30 Ventilatory Support System (2012), 8 descendants of its own
- K113288: Vpap ST-a (2012), 7 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. Various model range with tidal volumes of — 20-70 ml for neonate, 70-250 ml for pediatric, and >150 ml for adult. Single patient use for a duration up to 24 hours.

Source page: https://510kreport.com/device/K013122
Methodology: https://510kreport.com/methodology