Cleared Traditional

K934677 - U. S. MEDICAL PS-3500 WARMER/INCUBATOR ...

K934677 is the FDA 510(k) clearance for U. S. MEDICAL PS-3500 WARMER/INCUBATOR ... by U.S. Medical Corp.. It is a Class 2 General Hospital device (product code FMT) cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K934677 · U.S. Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
280d
Days
Class 2
Risk

K934677 is an FDA 510(k) clearance for the U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by U.S. Medical Corp. (Higgaum, US). The FDA issued a Cleared decision on July 5, 1994 after a review of 280 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.

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Submission Details

510(k) Number K934677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1993
Decision Date July 05, 1994
Days to Decision 280 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
151d slower than avg
Panel avg: 129d · This submission: 280d
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 36
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K934677.
INFANT WARMER SYSTEM
K963058 · Ohmeda Medical · Oct 1996
RW RESUCITAIRE INFANT RADIANT WARMER
K940951 · Air-Shields, Inc. · May 1995
STABILET
K942904 · Hill-Rom, Inc. · Sep 1994
KLEAR-TEMP
K926030 · Cas Medical Systems, Inc. · Feb 1994
HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO
K925006 · Deroyal Industries, Inc. · Jan 1994
OHIO INFANT WARMER SYSTEM
K921766 · Ohmeda Medical · Apr 1993