Cleared Traditional

K921766 - OHIO INFANT WARMER SYSTEM (FDA 510(k) Clearance)

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

K921766 · Ohmeda Medical · General Hospital
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Apr 1993
Decision
374d
Days
Class 2
Risk

K921766 is an FDA 510(k) clearance for the OHIO INFANT WARMER SYSTEM. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Ohmeda Medical (Columbia, US). The FDA issued a Cleared decision on April 23, 1993 after a review of 374 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5130 - 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. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K921766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1992
Decision Date April 23, 1993
Days to Decision 374 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
246d slower than avg
Panel avg: 128d · This submission: 374d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMT Warmer, Infant Radiant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5130
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.