Cleared Traditional

K912444 - MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 128d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.