Cleared Traditional

K921547 - ADVANTAGE

K921547 is an FDA 510(k) clearance for ADVANTAGE, manufactured by Kci. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 486-day FDA review.

K921547 · Kci · General Hospital
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Jul 1993
Decision
486d
Days
Class 2
Risk

K921547 is an FDA 510(k) clearance for the ADVANTAGE. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Kci (San Antonio, US). The FDA issued a Cleared decision on July 23, 1993 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 Kci devices

FDA 510(k) Submission Details - K921547

510(k) Number K921547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1992
Decision Date July 23, 1993
Days to Decision 486 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
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.

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 63
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K921547.
STABILET
K942904 · Hill-Rom, Inc. · Sep 1994
KLEAR-TEMP
K926030 · Cas Medical Systems, Inc. · Feb 1994
HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO
K925006 · Deroyal Industries, Inc. · Jan 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