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
SUBSCRIBE / SIGN IN
K862432Substantially Equivalent

Hepacron Pureair-Zone System

Hepacron, Inc., Louisville KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862432 is the FDA 510(k) clearance record for HEPACRON PUREAIR-ZONE SYSTEM, a class II device, cleared for Hepacron, Inc. on under FDA product code FRF (Cleaner, Air, Medical Recirculating). FDA records list one 510(k) clearance for Hepacron, Inc. As of , FDA records show no recalls naming K862432.

Clearance record

Decision date
Received
(112 days to decision)
Product code
FRF Cleaner, Air, Medical Recirculating
Regulation
21 CFR 880.5045
Device class
Class II
Review panel
General Hospital
Applicant
Hepacron, Inc. Post Office Box 922, Louisville KY
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