# K030990: Datex-Ohmeda Mini-Filter/S and Uni-Filter Junior

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda
- Decided: Jun 25, 2003 after 89 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: 4 generations back to K941381 (1994). 11 ancestors in all.
6 later devices descend from it; 2 cite it directly.
2 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023641: Datex-Ohmeda Hmef Mini, Datex-Ohmeda (2002) Summary page 2.
- K941536: Barrierbac and Barrierbac S, Mallinckrodt Medical (1994) Summary page 1.

## 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
- K043120: Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-Filter (2005), 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
Datex-Ohmeda 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 Mini-Filter/S can also be used for gas sampling. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K030990
Methodology: https://510kreport.com/methodology