# K014282: Bacstop Filter,Bacstop Filter/Hme

- Pathway: 510(k) (Traditional)
- Applicant: Munktell Filter AB
- Decided: Jun 26, 2002 after 181 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: 1 generation back to K881657 (1988). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881657: Humid-Vent Filter, Gibeck Respiration (1988) Summary page 1.
- K945359: Aqua+I-F, I-H, I-FH, II-H, II-FH, Iii-H, Artema Medical AB (1995) Summary page 1.
- K941381: Hygrobac,S Hygroboy and Hygrobaby, Mallinckrodt Medical (1994) Summary page 1.
- 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
- 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
For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired and to add and retain moisture in the circuit as required. For patients with a tidal volume 150-500 ml (pediatrics) and >250 ml (adults). Single patient use. Duration of use up to 24 hours.

Source page: https://510kreport.com/device/K014282
Methodology: https://510kreport.com/methodology