Cleared Special

RESUSCITAIRE RADIANT WARMER (K003335) - FDA 510(k) Clearance

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

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K003335 · Hill-Rom Air-Shields · General Hospital
Download Printable Device Report (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.

View all Hill-Rom Air-Shields devices

Submission Details

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
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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

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