Cleared Traditional

K912000 - TYPE INTERFACE 9271/1 INCUBATOR/WARMER (FDA 510(k) Clearance)

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

K912000 · S & W Medico Teknik · General Hospital
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Sep 1992
Decision
516d
Days
Class 2
Risk

K912000 is an FDA 510(k) clearance for the TYPE INTERFACE 9271/1 INCUBATOR/WARMER. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by S & W Medico Teknik (Denmark, DK). The FDA issued a Cleared decision on September 21, 1992 after a review of 516 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5400 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

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Submission Details

510(k) Number K912000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1991
Decision Date September 21, 1992
Days to Decision 516 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
388d slower than avg
Panel avg: 128d · This submission: 516d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMZ Incubator, Neonatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5400
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.