# K191909: HepaShield Bacterial Viral Breathing System Filter

- Pathway: 510(k) (Traditional)
- Applicant: Flexicare Medical Limited.
- Decided: Mar 23, 2020 after 250 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 K013093 (2002). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013093: Pall Ultipor Anesthesia Breathing System, Pall Medical (2002) Summary page 4.

## Most influential descendants
- K221836: Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (2022), 0 descendants of its own
- K210352: GGM Breathing Circuit Bacterial Filter (2022), 0 descendants of its own

## Indications for use
Flexicare's HepaShield Bacterial Viral Breathing System Filters are intended to reduce the transmission of bacteria and viruses to/from a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired. Flexicare's HepaShield Bacterial Viral Breathing System Filters are single use devices for use on a single patient for up to 24hrs and are available in Adult size. Flexicare's HepaShield Bacterial Viral Breathing System Filters are designed to be used in hospital environments by trained personnel.

Source page: https://510kreport.com/device/K191909
Methodology: https://510kreport.com/methodology