510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K112728Substantially Equivalent

Hepairx Ventilating Air Purifier

Air Innovations, Inc., North Syracuse NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K112728 is the FDA 510(k) clearance record for HEPAIRX VENTILATING AIR PURIFIER, a class II device, cleared for Air Innovations, Inc. on under FDA product code FRF (Cleaner, Air, Medical Recirculating). FDA records list one 510(k) clearance for Air Innovations, Inc. As of , FDA records show no recalls naming K112728.

Clearance record

Decision date
Received
(491 days to decision)
Product code
FRF Cleaner, Air, Medical Recirculating
Regulation
21 CFR 880.5045
Device class
Class II
Review panel
General Hospital
Applicant
Air Innovations, Inc. 7000 Perforance Dr., North 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