Cleared Traditional

K874880 - COLORED CASTING TAPE CARAGLAS(TM GREEN

K874880 is an FDA 510(k) clearance for COLORED CASTING TAPE CARAGLAS(TM GREEN, manufactured by Synthetic Mfg., Inc.. The device is a Class 1 Orthopedic device with product code LGF cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K874880 · Synthetic Mfg., Inc. · Orthopedic device
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Dec 1987
Decision
29d
Days
Class 1
Risk

K874880 is an FDA 510(k) clearance for the COLORED CASTING TAPE CARAGLAS(TM GREEN. Classified as Component, Cast (product code LGF), Class I - General Controls.

Submitted by Synthetic Mfg., Inc. (Martinez, US). The FDA issued a Cleared decision on December 30, 1987 after a review of 29 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K874880

510(k) Number K874880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1987
Decision Date December 30, 1987
Days to Decision 29 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
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 26
Devices cleared under the same product code (LGF) and FDA review panel - the closest regulatory comparables to K874880.
COOL CAST(R)
K903946 · Hawthorne Products, Inc. · Dec 1990
CARAGLAS XTRA SYNTHETIC CASTING TAPE
K896634 · Buckman Co., Inc. · Jun 1990
SYNTHETIC CAST TAPE
K883294 · Carapace, Inc. · Aug 1988
CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135
K873717 · Martin Medical · Oct 1987
CHILD WALKING HEEL PRODUCT NO. 4183-132
K873718 · Martin Medical · Oct 1987
PEDESTAL WALKING HEEL PRODUCT NO. 4183-133
K873722 · Martin Medical · Oct 1987
K874880 · COLORED CASTING TAPE CARAGLAS(TM GREEN
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