ADVANCED AIR PURIFICATION SYSTEM - Hepa Air Cleaning System

510(k) K012549

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK012549	Date4 Feb 2002Cleared	StatusActive

1 recall · FDA

- Terminated Z-0933-2012 FDA Not yet classified initiated 9 Jan 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 fire within the units.

1 jurisdiction

United States — FDA 510(k) Active

510(k)

510(k) Number: K012549
FDA Product Code: FRF
Models / Variants: Advanced Air Purification System
Hepa Air Cleaning System