Cleared Traditional

K030901 - MEDTRADE PRODICT'S SOOTHING GEL PATCH (FDA 510(k) Clearance)

Class I General Hospital device.

K030901 · Medtrade Products , Ltd. · General Hospital
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Nov 2004
Decision
613d
Days
Class 1
Risk

K030901 is an FDA 510(k) clearance for the MEDTRADE PRODICT'S SOOTHING GEL PATCH. Classified as Nursing Pad, Hydrogel (product code NTC), Class I - General Controls.

Submitted by Medtrade Products , Ltd. (Cheshire, GB). The FDA issued a Cleared decision on November 26, 2004 after a review of 613 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5630 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Medtrade Products , Ltd. devices

Submission Details

510(k) Number K030901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2003
Decision Date November 26, 2004
Days to Decision 613 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
485d slower than avg
Panel avg: 128d · This submission: 613d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NTC Nursing Pad, Hydrogel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5630
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.