Cleared Traditional

K955320 - PROTEC COTTON PADDING BANDAGE (FDA 510(k) Clearance)

Class I Orthopedic device.

K955320 · Derivadas Degasa S.A. DE C.V. · Orthopedic device
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Jan 1996
Decision
67d
Days
Class 1
Risk

K955320 is an FDA 510(k) clearance for the PROTEC COTTON PADDING BANDAGE. Classified as Component, Cast (product code LGF), Class I - General Controls.

Submitted by Derivadas Degasa S.A. DE C.V. (Palm Harobor, US). The FDA issued a Cleared decision on January 26, 1996 after a review of 67 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.

View all Derivadas Degasa S.A. DE C.V. devices

Submission Details

510(k) Number K955320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1995
Decision Date January 26, 1996
Days to Decision 67 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 122d · This submission: 67d
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.