Cleared Traditional

K903946 - COOL CAST(R)

K903946 is an FDA 510(k) clearance for COOL CAST, manufactured by Hawthorne Products, Inc.. The device is a Class 1 Orthopedic device with product code LGF cleared through the Traditional 510(k) pathway after a 126-day FDA review.

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.

FDA 510(k) Submission Details - K903946

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.

LGF Device Classification - Class 1, General Controls

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.

Regulatory Peers - LGF Component, Cast

All 19
Devices cleared under the same product code (LGF) and FDA review panel - the closest regulatory comparables to K903946.
QUICK-CAST IMMOBILIZER
K932507 · Landec Corp. · Feb 1994
CARAPACE STERILE CAST PADDING
K931672 · Carapace, Inc. · Dec 1993
ARTIFLEX(TM)
K910274 · Beiersdorf, Inc. · Mar 1991
CARAGLAS XTRA SYNTHETIC CASTING TAPE
K896634 · Buckman Co., Inc. · Jun 1990
SYNTHETIC CAST TAPE
K883294 · Carapace, Inc. · Aug 1988
COLORED CASTING TAPE (RED AND BLUE)
K870404 · Buckman Co., Inc. · Feb 1987
K903946 · COOL CAST(R)
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