Cleared Traditional

K853926 - NEOCARE MODEL 800 INFANT RADIANT WARMER

K853926 is an FDA 510(k) clearance for NEOCARE MODEL 800 INFANT RADIANT WARMER, manufactured by Draeger Medical, Inc.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K853926 · Draeger Medical, Inc. · General Hospital
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Feb 1986
Decision
155d
Days
Class 2
Risk

K853926 is an FDA 510(k) clearance for the NEOCARE MODEL 800 INFANT RADIANT WARMER. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on February 26, 1986 after a review of 155 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 Draeger Medical, Inc. devices

FDA 510(k) Submission Details - K853926

510(k) Number K853926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1985
Decision Date February 26, 1986
Days to Decision 155 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 129d · This submission: 155d
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 37
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K853926.
BIRTHING ROOM WARMER
K871594 · Air-Shields, Inc. · Jun 1987
OHMEDA AUXILIARY POWER SYSTEM
K863208 · Ohmeda Medical · Oct 1986
DELIVERY ROOM WARMER
K861781 · Air-Shields, Inc. · Jul 1986
NEO SHIELD
K852943 · Gaymar Industries, Inc. · Nov 1985
OHMEDA HEAT REFLECTING PATCH
K853351 · Ohmeda Medical · Oct 1985
NEOGUARD REFLECTOR
K853794 · Cas Medical Systems, Inc. · Oct 1985