# K012549: Advanced Air Purification System; Hepa Air Cleaning System

- Pathway: 510(k) (Traditional)
- Applicant: Healthway Products, Inc.
- Decided: Feb 4, 2002 after 181 days
- Product code: FRF (Cleaner, Air, Medical Recirculating)
- Device class: 2
- Regulation: 21 CFR 880.5045
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K072185: Airistar Air Purification System, Model 500 & 1000 (2008), 0 descendants of its own

## Recalls of this device
- Jan 9, 2012 · Not classified · Z-0933-2012: The Company is recalling certain serial numbers of HealthWay Model 20600-3 and CleanStation Model CS20000 air purifiers because of a potential risk of electrical arcing that could cause overheating or

## Indications for use
A device used to remove particles from the air for medical purposes

Source page: https://510kreport.com/device/K012549
Methodology: https://510kreport.com/methodology