# K964204: Engstrom Hmef 1000

- Pathway: 510(k) (Traditional)
- Applicant: Datex Engstrom AB
- Decided: Nov 13, 1996 after 76 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
No predicates in its family tree.
13 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K021265: Datex-Ohmeda Hmef 500 (2002), 11 descendants of its own
- 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

Source page: https://510kreport.com/device/K964204
Methodology: https://510kreport.com/methodology