510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912444Substantially Equivalent

Microbact 12A System, 12B System, and 24E System

Radiometer America, Inc, Westlake OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912444 is the FDA 510(k) clearance record for MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM, a class II device, cleared for Radiometer America, Inc. on under FDA product code LGM (Chamber, Patient Isolation). FDA records list 50 510(k) clearances for Radiometer America, Inc., from to . As of , FDA records show no recalls naming K912444.

Clearance record

Decision date
Received
(260 days to decision)
Product code
LGM Chamber, Patient Isolation
Regulation
21 CFR 880.5450
Device class
Class II
Review panel
General Hospital
Applicant
Radiometer America, Inc. 811 Sharon Dr., Westlake OH
510(k) summary
Statement
Third party review
No

Clearances, product code LGM

Trailing 12 months

FDA records hold no clearances under product code LGM in the trailing twelve months.

FDA records show no clearances under product code LGM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LGM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260