# K040712: Air Safety Hepa, Model 3500

- Pathway: 510(k) (Traditional)
- Applicant: Air Safety, Ltd.
- Decided: Jun 3, 2004 after 77 days
- Product code: MOD (Accessory To Continuous Ventilator (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5895
- 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 K894316 (1989). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990177: Nellcor Puritan Bennett Achieva Ventilator and Report Generator, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.
- K013089: Ems Hepa Filter and Hme Combinations, Engineered Medical Systems (2002) Summary page 1.

## Indications for use
Model 3500/01 is a replacement part for the ventilator. The Inlet Filter removes particles of 0.3 micron size (or larger) from entering the ventilator. It is a HEPA grade particulate filter for use with the NPB Achieva or LP 10 ventilators. The filter is in the gas flow pathway.

Source page: https://510kreport.com/device/K040712
Methodology: https://510kreport.com/methodology