510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012549Substantially Equivalent

Advanced Air Purification System; Hepa Air Cleaning System

Healthway Products, Inc., Syracuse NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012549 is the FDA 510(k) clearance record for ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM, a class II device, cleared for Healthway Products, Inc. on under FDA product code FRF (Cleaner, Air, Medical Recirculating). FDA records list one 510(k) clearance for Healthway Products, Inc. As of , FDA records show one recall naming K012549.

Clearance record

Decision date
Received
(181 days to decision)
Product code
FRF Cleaner, Air, Medical Recirculating
Regulation
21 CFR 880.5045
Device class
Class II
Review panel
General Hospital
Applicant
Healthway Products, Inc. P.O. Box 2729, Syracuse NY
510(k) summary
Statement
Third party review
No

Clearances, product code FRF

Trailing 12 months
1 clearance under product code FRF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FRF, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260