Cleared Traditional

K953489 - DRAGER INFANT RADIANT WARMERN RH600

K953489 is an FDA 510(k) clearance for DRAGER INFANT RADIANT WARMERN RH600, manufactured by Drager, Inc.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K953489 · Drager, Inc. · General Hospital
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Feb 1996
Decision
199d
Days
Class 2
Risk

K953489 is an FDA 510(k) clearance for the DRAGER INFANT RADIANT WARMERN RH600. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Drager, Inc. (Chantilly, US). The FDA issued a Cleared decision on February 9, 1996 after a review of 199 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 Drager, Inc. devices

FDA 510(k) Submission Details - K953489

510(k) Number K953489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1995
Decision Date February 09, 1996
Days to Decision 199 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
70d slower than avg
Panel avg: 129d · This submission: 199d
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 41
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K953489.
BABYTHERM 8004 BABYTHERM 8010
K971198 · Drager, Inc. · Oct 1997
STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)
K970074 · Hill-Rom, Inc. · Apr 1997
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