Cleared Traditional

K903946 - COOL CAST(R) (FDA 510(k) Clearance)

Class I Orthopedic device.

K903946 · Hawthorne Products, Inc. · Orthopedic device
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Dec 1990
Decision
126d
Days
Class 1
Risk

K903946 is an FDA 510(k) clearance for the COOL CAST(R). Classified as Component, Cast (product code LGF), Class I - General Controls.

Submitted by Hawthorne Products, Inc. (Dunkirk, US). The FDA issued a Cleared decision on December 31, 1990 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.5940 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Hawthorne Products, Inc. devices

Submission Details

510(k) Number K903946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1990
Decision Date December 31, 1990
Days to Decision 126 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 122d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LGF Component, Cast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5940
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.