Cleared Traditional

K833802 - INFANT WARMER

K833802 is an FDA 510(k) clearance for INFANT WARMER, manufactured by Kinetic Concepts, Inc.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K833802 · Kinetic Concepts, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
156d
Days
Class 2
Risk

K833802 is an FDA 510(k) clearance for the INFANT WARMER. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Kinetic Concepts, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1984 after a review of 156 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 Kinetic Concepts, Inc. devices

FDA 510(k) Submission Details - K833802

510(k) Number K833802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1983
Decision Date April 05, 1984
Days to Decision 156 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
27d slower than avg
Panel avg: 129d · This submission: 156d
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 39
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K833802.
OHMEDA HEAT REFLECTING PATCH
K853351 · Ohmeda Medical · Oct 1985
NEOGUARD REFLECTOR
K853794 · Cas Medical Systems, Inc. · Oct 1985
OHMEDA 5000 INFANT WARMER SYSTEM
K851449 · Ohmeda Medical · Jun 1985
OHIO 3000 INFANT WARMER SYSTEM
K840857 · Ohio Medical Products · Mar 1984
OHIO 3300 INFANT WARMER SYSTEM
K840858 · Ohio Medical Products · Mar 1984
RESUSCITAIRE
K830748 · Vickers America Medical Corp. · Jun 1983