# K043120: Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-Filter

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Mar 1, 2005 after 109 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: 5 generations back to K941381 (1994). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030990: Datex-Ohmeda Mini-Filter/S and Uni-Filter Junior, Datex-Ohmeda (2003) Summary page 1.
- K990949: Clear-Guard II, Clear-Therm Hmef, Clear-Therm Hmef W/ Flextube, Clear Guard 11 W/ Gas Monitoring Port, Intersurgical, Inc. (1999) Summary page 1.

## Most influential descendants
- K072582: Provox Micron Hme (2008), 0 descendants of its own

## Indications for use
Filters can be used to provide filtration for reducing possible cross contamination between patient and equipment. Filters are for use in the hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators for filtering particles including bacteria, viruses and dust from C02-absorbers.The Uni-Filter/S, angled Uni-Filter/S and Mini-Filter/S can also be used for gas sampling. The device for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K043120
Methodology: https://510kreport.com/methodology