Cleared Traditional

K921766 - OHIO INFANT WARMER SYSTEM

K921766 is the FDA 510(k) clearance for OHIO INFANT WARMER SYSTEM by Ohmeda Medical. It is a Class 2 General Hospital device (product code FMT) cleared through the Traditional 510(k) pathway after a 374-day FDA review.

K921766 · Ohmeda Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
374d
Days
Class 2
Risk

K921766 is an FDA 510(k) clearance for the OHIO 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 April 23, 1993 after a review of 374 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 Ohmeda Medical devices

Submission Details

510(k) Number K921766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1992
Decision Date April 23, 1993
Days to Decision 374 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
245d slower than avg
Panel avg: 129d · This submission: 374d
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 23
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K921766.
GIRAFFE AND PANDA WARMER
K070377 · Ohmeda Medical · Jul 2007
INFANT WARMER SYSTEM
K963058 · Ohmeda Medical · Oct 1996
HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO
K925006 · Deroyal Industries, Inc. · Jan 1994
OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM
K884160 · Ohmeda Medical · Nov 1988
OHMEDA AUXILIARY POWER SYSTEM
K863208 · Ohmeda Medical · Oct 1986
NEOCARE MODEL 800 INFANT RADIANT WARMER
K853926 · Draeger Medical, Inc. · Feb 1986