# K033008: Air Safety Hepa and Non-Hepa Filters

- Pathway: 510(k) (Traditional)
- Applicant: Air Safety, Ltd.
- Decided: May 13, 2004 after 230 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 K941381 (1994). 9 ancestors in all.
29 later devices descend from it; 4 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)
- K013089: Ems Hepa Filter and Hme Combinations, Engineered Medical Systems (2002) Summary page 1.
- K013122: Ems Electrostatic Fliter and Hme Combination, Engineered Medical Systems (2002) Summary page 1.
- K002201: Electrostatic Hydrophobic Breathing Filter, Sims Portex, Inc. (2001) Summary page 1.

## Cited in the summary but kept off the family tree
- K964540: Nellcor Puritan Bennett, 740 Ventilator System, Puritan Bennett Corp. (1997). Our reading of the summary gave K964540, FDA’s number for Nellcor Puritan Bennett, 740 Ventilator System (Puritan Bennett Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “NPB D/X7”. Kept off the family tree. Summary page 1.
- K984379: Nellcor Puritan Bennett, 760 Ventilator System, Puritan Bennett Corp. (1998). Our reading of the summary gave K984379, FDA’s number for Nellcor Puritan Bennett, 760 Ventilator System (Puritan Bennett Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “NPB D/X7”. Kept off the family tree. Summary page 1.

## Most influential descendants
- 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
- K113288: Vpap ST-a (2012), 7 descendants of its own
- K121623: Bipap a 40 Ventilatory Support System (2012), 6 descendants of its own

## Indications for use
Anesthesia / Respiratory Filters For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired. Model - HEPA filter 3000/04 - Single patient use for exhalation limb of circuit on NPB 700 series ventilators Models - HEPA filters - 6500/01, 6888/01, 8222/01, 8444/01 Model - Non-HEPA filters - 4000/01 Single patient use up to 24 hours. Patient tidal volumes > 150 ml, when applicable.

Source page: https://510kreport.com/device/K033008
Methodology: https://510kreport.com/methodology