Cleared Traditional

K913945 - STABILET INFANT RADIANT WARMER MODEL 2000C

K913945 is an FDA 510(k) clearance for STABILET INFANT RADIANT WARMER MODEL 2000C, manufactured by Hill-Rom, Inc.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K913945 · Hill-Rom, Inc. · General Hospital
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Feb 1992
Decision
161d
Days
Class 2
Risk

K913945 is an FDA 510(k) clearance for the STABILET INFANT RADIANT WARMER MODEL 2000C. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on February 12, 1992 after a review of 161 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.

FDA 510(k) Submission Details - K913945

510(k) Number K913945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1991
Decision Date February 12, 1992
Days to Decision 161 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 129d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMT Device Classification - Class 2, Special Controls

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 91
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K913945.
OHIO INFANT WARMER SYSTEM
K921766 · Ohmeda Medical · Apr 1993
VSI 1000
K912921 · Vitaltrends Technology, Inc. · Oct 1992
THERMAL PROBE COVER
K915831 · Vermont Medical, Inc. · Jun 1992
PATIENT WARMER MODEL 100C
K910915 · Developmed Corp. · Jul 1991
PREEMICARE SERIES 2000 INFANT WARMER
K885350 · Preemicare Corp. · Aug 1989
MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET
K884280 · Gempco, Inc. · Dec 1988
K913945 · STABILET INFANT RADIANT WARMER MODEL 2000C
Download PDF Hill-Rom, Inc.