Cleared Traditional

K963058 - INFANT WARMER SYSTEM

K963058 is an FDA 510(k) clearance for INFANT WARMER SYSTEM, manufactured by Ohmeda Medical. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K963058 · Ohmeda Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
56d
Days
Class 2
Risk

K963058 is an FDA 510(k) clearance for the INFANT WARMER SYSTEM. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Ohmeda Medical (Columbia, US). The FDA issued a Cleared decision on October 1, 1996 after a review of 56 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ohmeda Medical devices

FDA 510(k) Submission Details - K963058

510(k) Number K963058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1996
Decision Date October 01, 1996
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
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 59
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K963058.
STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)
K970074 · Hill-Rom, Inc. · Apr 1997
KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)
K964401 · Ludlow Technical Products · Feb 1997
FIRST TOUCH DISPOSABLES TEMPERATURE PROBES
K950422 · First Touch Disposables, Inc. · Jan 1997
ACCUTEMP PROBE
K960080 · Kentec Medical, Inc. · May 1996
TEMPERATURE PROBE-TP150
K952800 · Contour Medical Technology, Inc. · Apr 1996
TEMPERATURE PROBE-TP250
K952801 · Contour Medical Technology, Inc. · Apr 1996