# K093426: Bact-Trap Hepa Midi

- Pathway: 510(k) (Traditional)
- Applicant: Pharma Systems AB
- Decided: Feb 22, 2010 after 111 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). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063125: Filterflo Hepa; Thermoflo Hepa (Filter / Hme), Arc Medical, Inc. (2007) Summary page 1.
- K033008: Air Safety Hepa and Non-Hepa Filters, Air Safety, Ltd. (2004) Summary page 1.

## Indications for use
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is required. It is single patient use, disposable for patients with Tidal Volumes > 150 ml. May be positioned at the machine end of the expiratory / inspiratory limb of the circuit, or at the patient end of the circuit.

Source page: https://510kreport.com/device/K093426
Methodology: https://510kreport.com/methodology