Cleared Traditional

K863208 - OHMEDA AUXILIARY POWER SYSTEM

K863208 is an FDA 510(k) clearance for OHMEDA AUXILIARY POWER 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 45-day FDA review.

K863208 · Ohmeda Medical · General Hospital
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Oct 1986
Decision
45d
Days
Class 2
Risk

K863208 is an FDA 510(k) clearance for the OHMEDA AUXILIARY POWER 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 3, 1986 after a review of 45 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 - K863208

510(k) Number K863208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1986
Decision Date October 03, 1986
Days to Decision 45 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
84d faster than avg
Panel avg: 129d · This submission: 45d
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 K863208.
WARM WEIGH MODELS I-20/W-30 INFANT SCALE
K872742 · Air-Shields, Inc. · Oct 1987
BIRTHING ROOM WARMER
K871594 · Air-Shields, Inc. · Jun 1987
YSI MODEL 801
K865012 · Yellow Springs Instrument Co., Inc. · Mar 1987
DELIVERY ROOM WARMER
K861781 · Air-Shields, Inc. · Jul 1986
NEOCARE MODEL 800 INFANT RADIANT WARMER
K853926 · Draeger Medical, Inc. · Feb 1986
NEO SHIELD
K852943 · Gaymar Industries, Inc. · Nov 1985