Cleared Traditional

K931672 - CARAPACE STERILE CAST PADDING

K931672 is an FDA 510(k) clearance for CARAPACE STERILE CAST PADDING, manufactured by Carapace, Inc.. The device is a Class 1 Orthopedic device with product code LGF cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K931672 · Carapace, Inc. · Orthopedic device
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Dec 1993
Decision
253d
Days
Class 1
Risk

K931672 is an FDA 510(k) clearance for the CARAPACE STERILE CAST PADDING. Classified as Component, Cast (product code LGF), Class I - General Controls.

Submitted by Carapace, Inc. (Broken Arrow, US). The FDA issued a Cleared decision on December 15, 1993 after a review of 253 days - an extended review cycle.

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 Carapace, Inc. devices

FDA 510(k) Submission Details - K931672

510(k) Number K931672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1993
Decision Date December 15, 1993
Days to Decision 253 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 122d · This submission: 253d
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 11
Devices cleared under the same product code (LGF) and FDA review panel - the closest regulatory comparables to K931672.
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
DELTA-LITE CASTING RESIN
K854554 · Johnson & Johnson Professionals, Inc. · Dec 1985
DELTA-LITE CASTING RESIN
K854341 · Johnson & Johnson Professionals, Inc. · Nov 1985