# K031653: Datex-Ohmeda Hmef 750

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda
- Decided: Jun 20, 2003 after 23 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: 3 generations back to K941381 (1994). 9 ancestors in all.
4 later devices descend from it; 2 cite it directly.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021265: Datex-Ohmeda Hmef 500, Datex-Ohmeda (2002) Summary page 2.

## Most influential descendants
- 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
- K221836: Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (2022), 0 descendants of its own
- K090738: Thermoflo HCH, Thermoflo Filter (2009), 0 descendants of its own

## Indications for use
The HMEF 750 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 750 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/K031653
Methodology: https://510kreport.com/methodology