# K102483: Sunset Healthcare Solutions Bacterial/Viral Hme Filter, Model BHF 104

- Pathway: 510(k) (Traditional)
- Applicant: Sunset Healthcare Solutions, LLC
- Decided: Sep 13, 2011 after 379 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.
No later device cites it as a predicate yet.
0 of 10 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.

## Indications for use
The BHF 104 is a disposable single-use filter for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross-contamination between patient and equipment. The BHF 104 is for use in hospital, ICU, anesthesia, and respiratory therapy.

Source page: https://510kreport.com/device/K102483
Methodology: https://510kreport.com/methodology