Cleared Traditional

K840858 - OHIO 3300 INFANT WARMER SYSTEM

K840858 is an FDA 510(k) clearance for OHIO 3300 INFANT WARMER SYSTEM, manufactured by Ohio Medical Products. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K840858 · Ohio Medical Products · General Hospital
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Mar 1984
Decision
28d
Days
Class 2
Risk

K840858 is an FDA 510(k) clearance for the OHIO 3300 INFANT WARMER SYSTEM. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Ohio Medical Products (Walker, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 28 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 Ohio Medical Products devices

FDA 510(k) Submission Details - K840858

510(k) Number K840858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date March 23, 1984
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
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 48
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K840858.
OHMEDA 5000 INFANT WARMER SYSTEM
K851449 · Ohmeda Medical · Jun 1985
INFANT WARMER
K833802 · Kinetic Concepts, Inc. · Apr 1984
OHIO 3000 INFANT WARMER SYSTEM
K840857 · Ohio Medical Products · Mar 1984
RESUSCITAIRE
K830748 · Vickers America Medical Corp. · Jun 1983
SAGE 2200 STERILE SPECIMEN CONTAINER
K813408 · Sage Products, Inc. · Jan 1982
WARMING LISTHTS #96H & 96HT
K812745 · J. H. Emerson Co. · Nov 1981