Cleared Traditional

INFANT RADIANT WARMER - MODELS IW910 AND IW920 (K970432) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970432 · Fisher & Paykel Electronics , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
92d
Days
Class 2
Risk

K970432 is an FDA 510(k) clearance for the INFANT RADIANT WARMER - MODELS IW910 AND IW920. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Fisher & Paykel Electronics , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on May 7, 1997 after a review of 92 days - within the typical 510(k) review window.

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 Fisher & Paykel Electronics , Ltd. devices

Submission Details

510(k) Number K970432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1997
Decision Date May 07, 1997
Days to Decision 92 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 129d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 18
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K970432.
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