Cleared Traditional

THEMALATOR. MODELS T-4-S, T-8-S, ETC. (K950350) - FDA 510(k) Clearance

Class I Physical Medicine device.

K950350 · Whitehall/Div Columbus Mckennon Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
53d
Days
Class 1
Risk

K950350 is an FDA 510(k) clearance for the THEMALATOR. MODELS T-4-S, T-8-S, ETC.. Classified as Unit, Heating, Powered (product code IRQ), Class I - General Controls.

Submitted by Whitehall/Div Columbus Mckennon Corp. (City Of Industry, US). The FDA issued a Cleared decision on March 24, 1995 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5950 - the FDA physical medicine 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 Whitehall/Div Columbus Mckennon Corp. devices

Submission Details

510(k) Number K950350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1995
Decision Date March 24, 1995
Days to Decision 53 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 115d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IRQ Unit, Heating, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5950
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.