510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K974682Substantially Equivalent

Microcon 800M, Microcon 400M, Microcon Exc, Microcon Ex, Microcon Wallmap

Biological Controls, Inc., Eatontown NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974682 is the FDA 510(k) clearance record for MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP, a class II device, cleared for Biological Controls, Inc. on under FDA product code FRF (Cleaner, Air, Medical Recirculating). FDA records list 2 510(k) clearances for Biological Controls, Inc., from to . As of , FDA records show no recalls naming K974682.

Clearance record

Decision date
Received
(39 days to decision)
Product code
FRF Cleaner, Air, Medical Recirculating
Regulation
21 CFR 880.5045
Device class
Class II
Review panel
General Hospital
Applicant
Biological Controls, Inc. One Industrial Way W., Eatontown NJ
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