Cleared Traditional

K931529 - INFANT WARMER

K931529 is an FDA 510(k) clearance for INFANT WARMER, manufactured by Medix I.C.S.A.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K931529 · Medix I.C.S.A. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
350d
Days
Class 2
Risk

K931529 is an FDA 510(k) clearance for the INFANT WARMER. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Medix I.C.S.A. (San Martin, Buenos Aires, AR). The FDA issued a Cleared decision on March 11, 1994 after a review of 350 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Medix I.C.S.A. devices

FDA 510(k) Submission Details - K931529

510(k) Number K931529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1993
Decision Date March 11, 1994
Days to Decision 350 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
221d slower than avg
Panel avg: 129d · This submission: 350d
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 60
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K931529.
DRAGER INFANT RADIANT WARMERN RH600
K953489 · Drager, Inc. · Feb 1996
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
HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO
K925006 · Deroyal Industries, Inc. · Jan 1994
OHIO INFANT WARMER SYSTEM
K921766 · Ohmeda Medical · Apr 1993