Cleared Abbreviated

K033040 - PHOENIX INFANT RADIANT WARMER, MODEL 100NWS (FDA 510(k) Clearance)

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

K033040 · International Hospital Supply Co. · General Hospital
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Dec 2003
Decision
79d
Days
Class 2
Risk

K033040 is an FDA 510(k) clearance for the PHOENIX INFANT RADIANT WARMER, MODEL 100NWS. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by International Hospital Supply Co. (Amsterdam, NL). The FDA issued a Cleared decision on December 17, 2003 after a review of 79 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all International Hospital Supply Co. devices

Submission Details

510(k) Number K033040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date December 17, 2003
Days to Decision 79 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 128d · This submission: 79d
Pathway characteristics
Standards-based clearance path.

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.