Cleared Traditional

K925006 - HYDRO-TEMP NICU AND SKIN SURFACE TEMPER...

K925006 is the FDA 510(k) clearance for HYDRO-TEMP NICU AND SKIN SURFACE TEMPER... by Deroyal Industries, Inc.. It is a Class 2 General Hospital device (product code FMT) cleared through the Traditional 510(k) pathway after a 486-day FDA review.

K925006 · Deroyal Industries, Inc. · General Hospital
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Jan 1994
Decision
486d
Days
Class 2
Risk

K925006 is an FDA 510(k) clearance for the HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on January 31, 1994 after a review of 486 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Deroyal Industries, Inc. devices

Submission Details

510(k) Number K925006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1992
Decision Date January 31, 1994
Days to Decision 486 days
Submission Type Traditional
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
357d slower than avg
Panel avg: 129d · This submission: 486d
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 35
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K925006.
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
OHIO INFANT WARMER SYSTEM
K921766 · Ohmeda Medical · Apr 1993
STABILET INFANT RADIANT WARMER MODEL 2000C
K913945 · Hill-Rom, Inc. · Feb 1992
OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM
K884160 · Ohmeda Medical · Nov 1988