# K072185: Airistar Air Purification System, Model 500 & 1000

- Pathway: 510(k) (Traditional)
- Applicant: Airistar Technologies, LLC
- Decided: Mar 27, 2008 after 234 days
- Product code: FRF (Cleaner, Air, Medical Recirculating)
- Device class: 2
- Regulation: 21 CFR 880.5045
- 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 K974682 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984116: Hepa-Care Air Cleaner American Air Filter Air Filtration System Models HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C, Abatement Technologies, Inc. (1999) Summary page 1.
- K023693: Mobile Particulate Contamination Control System, Model M-100, Airex, Inc. (2003) Summary page 1.
- K012549: Advanced Air Purification System; Hepa Air Cleaning System, Healthway Products, Inc. (2002) Summary page 1.

## Indications for use
Intended for use in filtering airborne particles from air for medical purposes.

Source page: https://510kreport.com/device/K072185
Methodology: https://510kreport.com/methodology