Cleared Traditional

YSI MODEL 801 (K865012) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K865012 · Yellow Springs Instrument Co., Inc. · General Hospital
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Mar 1987
Decision
71d
Days
Class 2
Risk

K865012 is an FDA 510(k) clearance for the YSI MODEL 801. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Yellow Springs Instrument Co., Inc. (Yellow Springs, US). The FDA issued a Cleared decision on March 4, 1987 after a review of 71 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 Yellow Springs Instrument Co., Inc. devices

Submission Details

510(k) Number K865012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1986
Decision Date March 04, 1987
Days to Decision 71 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 129d · This submission: 71d
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 17
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K865012.
INFANT WARMER SYSTEM
K963058 · Ohmeda Medical · Oct 1996
OHIO INFANT WARMER SYSTEM
K921766 · Ohmeda Medical · Apr 1993
OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM
K884160 · Ohmeda Medical · Nov 1988
OHMEDA AUXILIARY POWER SYSTEM
K863208 · Ohmeda Medical · Oct 1986
OHMEDA HEAT REFLECTING PATCH
K853351 · Ohmeda Medical · Oct 1985
OHMEDA 5000 INFANT WARMER SYSTEM
K851449 · Ohmeda Medical · Jun 1985