Cleared Traditional

EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 (K050524) - FDA 510(k) Clearance

Class I Physical Medicine device.

K050524 · Marda Medical, Inc. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Sep 2005
Decision
196d
Days
Class 1
Risk

K050524 is an FDA 510(k) clearance for the EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000. Classified as Unit, Heating, Powered (product code IRQ), Class I - General Controls.

Submitted by Marda Medical, Inc. (Jensen Beach, US). The FDA issued a Cleared decision on September 14, 2005 after a review of 196 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Marda Medical, Inc. devices

Submission Details

510(k) Number K050524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2005
Decision Date September 14, 2005
Days to Decision 196 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
81d slower than avg
Panel avg: 115d · This submission: 196d
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.