Cleared Traditional

K912444 - MICROBACT 12A SYSTEM

K912444 is an FDA 510(k) clearance for MICROBACT 12A SYSTEM, manufactured by Radiometer America, Inc.. The device is a Class 2 General Hospital device with product code LGM cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K912444 · Radiometer America, Inc. · General Hospital
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Feb 1992
Decision
260d
Days
Class 2
Risk

K912444 is an FDA 510(k) clearance for the MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM. Classified as Chamber, Patient Isolation (product code LGM), Class II - Special Controls.

Submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on February 18, 1992 after a review of 260 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5450 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Radiometer America, Inc. devices

FDA 510(k) Submission Details - K912444

510(k) Number K912444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1991
Decision Date February 18, 1992
Days to Decision 260 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 129d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGM Device Classification - Class 2, Special Controls

Product Code LGM Chamber, Patient Isolation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LGM Chamber, Patient Isolation

Devices cleared under the same product code (LGM) and FDA review panel - the closest regulatory comparables to K912444.
Carecube Negative Pressure Isolation Chamber
K231256 · Carecubes, Inc. · Jan 2024
MODEL 7-AT TREATMENT CHAMBER
K896721 · J. H. Emerson Co. · Jan 1990
INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE
K874306 · Busse Hospital Disposables, Inc. · Mar 1988
ANAGO ISOLATION MASK (#80-950)
K864116 · Anago, Inc. · Nov 1986
ISOLATION MASK I.C.S.
K831062 · American Threshold Industries, Inc. · Apr 1983
STRETCHER TRANSIT ISOLATER #122
K790657 · Vickers America Medical Corp. · Jul 1979