510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K072185Substantially Equivalent

Airistar Air Purification System, Model 500 & 1000

Airistar Technologies, LLC, Deer Field IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072185 is the FDA 510(k) clearance record for AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000, a class II device, cleared for Airistar Technologies, LLC on under FDA product code FRF (Cleaner, Air, Medical Recirculating). FDA records list one 510(k) clearance for Airistar Technologies, LLC. As of , FDA records show no recalls naming K072185.

Clearance record

Decision date
Received
(234 days to decision)
Product code
FRF Cleaner, Air, Medical Recirculating
Regulation
21 CFR 880.5045
Device class
Class II
Review panel
General Hospital
Applicant
Airistar Technologies, LLC P.O. Box 7007, Deer Field IL
510(k) summary
Summary PDF
Third party review
Yes

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