Cleared Traditional

K884160 - OHMEDA - OHIO 3500 INFANT WARMER SYSTEM

K884160 is the FDA 510(k) clearance for OHMEDA - OHIO 3500 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 48-day FDA review.

K884160 · Ohmeda Medical · General Hospital
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Nov 1988
Decision
48d
Days
Class 2
Risk

K884160 is an FDA 510(k) clearance for the OHMEDA - OHIO(R) 3500 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 November 21, 1988 after a review of 48 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

Submission Details

510(k) Number K884160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1988
Decision Date November 21, 1988
Days to Decision 48 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 129d · This submission: 48d
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 K884160.
INFANT WARMER SYSTEM
K963058 · Ohmeda Medical · Oct 1996
HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO
K925006 · Deroyal Industries, Inc. · Jan 1994
OHIO INFANT WARMER SYSTEM
K921766 · Ohmeda Medical · Apr 1993
OHMEDA AUXILIARY POWER SYSTEM
K863208 · Ohmeda Medical · Oct 1986
NEOCARE MODEL 800 INFANT RADIANT WARMER
K853926 · Draeger Medical, Inc. · Feb 1986
OHMEDA HEAT REFLECTING PATCH
K853351 · Ohmeda Medical · Oct 1985