# K251583: Ambu® Virobac II® Exhalation Filter

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Apr 30, 2026 after 342 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: 2 generations back to K851070 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954490: Mercury Medical CPR Bag Exhalation Filter, Mercury Medical (1996) Summary page 5.

## Indications for use
The Virobac II® Exhalation Filter is a viral/bacterial filter intended for use when the care provider desires to prevent the transmission of viruses or bacteria from patients receiving respiratory support.

Source page: https://510kreport.com/device/K251583
Methodology: https://510kreport.com/methodology