Cleared Traditional

K865012 - YSI MODEL 801 (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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
57d faster than avg
Panel avg: 128d · 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 91
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K865012.
Babyroo TN300
K243606 · Draeger Medical Systems, Inc. · Jan 2025
Babyroo TN300
K230278 · Draeger Medical Systems, Inc. · May 2023
Giraffe Omnibed Carestation CS1
K213551 · Datex-Ohmeda, Inc. · Mar 2022
Panda iRes Warmer, Giraffe Warmer
K201628 · Ge Healthcare · Feb 2021
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
K200319 · Deroyal Industries, Inc. · Apr 2020
Hydro-Temp Neonatal Skin Temperature Probe Cover
K191425 · Deroyal Industries, Inc. · Jan 2020