Cleared Traditional

K910915 - PATIENT WARMER MODEL 100C

K910915 is the FDA 510(k) clearance for PATIENT WARMER MODEL 100C by Developmed Corp.. It is a Class 2 General Hospital device (product code FMT) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K910915 · Developmed Corp. · General Hospital
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Jul 1991
Decision
133d
Days
Class 2
Risk

K910915 is an FDA 510(k) clearance for the PATIENT WARMER MODEL 100C. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Developmed Corp. (Houston, US). The FDA issued a Cleared decision on July 16, 1991 after a review of 133 days - within the typical 510(k) review window.

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 Developmed Corp. devices

Submission Details

510(k) Number K910915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1991
Decision Date July 16, 1991
Days to Decision 133 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 129d · This submission: 133d
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 19
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K910915.
INFANT WARMER SYSTEM
K963058 · Ohmeda Medical · Oct 1996
HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO
K925006 · Deroyal Industries, Inc. · Jan 1994
OHIO INFANT WARMER SYSTEM
K921766 · Ohmeda Medical · Apr 1993
OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM
K884160 · Ohmeda Medical · Nov 1988
OHMEDA AUXILIARY POWER SYSTEM
K863208 · Ohmeda Medical · Oct 1986
NEOCARE MODEL 800 INFANT RADIANT WARMER
K853926 · Draeger Medical, Inc. · Feb 1986