# K050953: Air Safety Model 3000/06 Filter Hepa Reusable

- Pathway: 510(k) (Traditional)
- Applicant: Air Safety, Ltd.
- Decided: Jun 29, 2005 after 75 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)
- K033008: Air Safety Hepa and Non-Hepa Filters, Air Safety, Ltd. (2004) Summary page 1.
- K890362: Omnifilter Main Flow Bacteria Filter, Puritan Bennett Corp. (1989) Summary page 1.

## Indications for use
Filtration of exhaled gases in the ventilator circuit. Model 3000/06 to be placed in the exhalation pathway of the ventilator circuit where filtration of the expired gases is desired. Filter is reusable up to 100 times, extended use as determined by the increase in airflow resistance, which is determined during self testing (SST) mode of the ventilator. For use with the Series 700 and 7200 NPB ventilators. Cleaning method - autoclaved - 30 minutes with 3 minutes at 134°C. Environment of Use -- Hospital, Sub-acute Institutions

Source page: https://510kreport.com/device/K050953
Methodology: https://510kreport.com/methodology