Cleared Special

K003335 - RESUSCITAIRE RADIANT WARMER

Also marketed or referenced as:
RESUSCITAIRE BIRTHING ROOM WARMER RESUSCITAIR WALL MOUNTED RADIANT WARMER

K003335 is an FDA 510(k) clearance for RESUSCITAIRE RADIANT WARMER, manufactured by Hill-Rom Air-Shields. The device is a Class 2 General Hospital device with product code FMT cleared through the Special 510(k) pathway after a 23-day FDA review.

K003335 · Hill-Rom Air-Shields · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
23d
Days
Class 2
Risk

K003335 is an FDA 510(k) clearance for the RESUSCITAIRE RADIANT WARMER. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Hill-Rom Air-Shields (Hatboro, US). The FDA issued a Cleared decision on November 17, 2000 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5130 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K003335

510(k) Number K003335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2000
Decision Date November 17, 2000
Days to Decision 23 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 90
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K003335.
RPI REPLACEMENT HEATING ELEMENTS
K020966 · Replacement Parts Industries, Inc. · Jun 2002
RPI SKIN OR AIR TEMPERATURE PROBE
K020219 · Replacement Parts Industries, Inc. · Apr 2002
SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC
K012229 · National Custom Ent., Inc. · Sep 2001
ATOM INFA WARMER V-505
K002355 · Atom Medical Corp · Oct 2000
INCUWARMER
K971366 · Hill-Rom, Inc. · Jan 1998
SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970
K972885 · Fisher & Paykel Electronics , Ltd. · Oct 1997
K003335 · RESUSCITAIRE RADIANT WARMER
Download PDF FDA Summary Hill-Rom Air-Shields