# K941536: Barrierbac and Barrierbac S

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Medical
- Decided: Apr 19, 1994 after 20 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
38 later devices descend from it; 3 cite it directly.
8 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013122: Ems Electrostatic Fliter and Hme Combination (2002), 33 descendants of its own
- K033008: Air Safety Hepa and Non-Hepa Filters (2004), 29 descendants of its own
- K060705: Carina Home (2006), 22 descendants of its own
- K103167: Stellar 150 (2011), 20 descendants of its own
- K113053: Bipap a 30 Ventilatory Support System (2012), 8 descendants of its own

## Recalls of this device
- Apr 29, 2021 · Class II · Z-1867-2021: The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.

Source page: https://510kreport.com/device/K941536
Methodology: https://510kreport.com/methodology