# K063526: A-M Systems Viromax Viral and Bacterial Filter

- Pathway: 510(k) (Traditional)
- Applicant: A-M Systems, Inc.
- Decided: Jun 29, 2007 after 219 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K792097 (1979). 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)
- K961914: Bacteria/Viral Filter, Hudson Respiratory Care, Inc. (1996) Summary page 1.

## Recalls of this device
- Apr 16, 2010 · Not classified · Z-1754-2010: CML, Inc. was notified by A-M Systems in a letter dated March 31, 2010 that they were recalling a component of their Xenon Kit (ViroMax viral and bacterial filter) because the filters may have a leak 
- Mar 31, 2010 · Not classified · Z-0308-2012: Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together.

## Indications for use
This device is indicated for use on all patient populations, in conjunction with other respiratory devices containing standard 155mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.

Source page: https://510kreport.com/device/K063526
Methodology: https://510kreport.com/methodology