Cleared Traditional

4002 INFANT SCALE FOR INCUBATORS AND WARMERS (K935609) - FDA 510(k) Clearance

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

K935609 · Scale-Tronix, Inc. · General Hospital
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Jul 1994
Decision
224d
Days
Class 2
Risk

K935609 is an FDA 510(k) clearance for the 4002 INFANT SCALE FOR INCUBATORS AND WARMERS. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Scale-Tronix, Inc. (Wheaton, US). The FDA issued a Cleared decision on July 1, 1994 after a review of 224 days - an extended review cycle.

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. 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 Scale-Tronix, Inc. devices

Submission Details

510(k) Number K935609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1993
Decision Date July 01, 1994
Days to Decision 224 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
95d slower than avg
Panel avg: 129d · This submission: 224d
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.

Regulatory Peers - FMT Warmer, Infant Radiant

All 7
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