# K021265: Datex-Ohmeda Hmef 500

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda
- Decided: Aug 30, 2002 after 130 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: 2 generations back to K941381 (1994). 8 ancestors in all.
11 later devices descend from it; 4 cite it directly.
2 of 20 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.
- K013089: Ems Hepa Filter and Hme Combinations, Engineered Medical Systems (2002) Summary page 2.

## Most influential descendants
- K023641: Datex-Ohmeda Hmef Mini (2002), 7 descendants of its own
- K030990: Datex-Ohmeda Mini-Filter/S and Uni-Filter Junior (2003), 6 descendants of its own
- K031653: Datex-Ohmeda Hmef 750 (2003), 4 descendants of its own
- K072002: Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55 (2008), 3 descendants of its own
- K132709: VR Medical Heat and Moisture Exchanger and Filter (2014), 1 descendant of its own

## Indications for use
The HMEF500 is a disposable single-use device indicated for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The HMEF 500 is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The device can be used on adult and pediatric patients. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K021265
Methodology: https://510kreport.com/methodology