Cleared Traditional

K903823 - SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K903823 · Smith and Nephew Donjoy, Inc. · General & Plastic Surgery device
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Jan 1991
Decision
149d
Days
Class 1
Risk

K903823 is an FDA 510(k) clearance for the SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Smith and Nephew Donjoy, Inc. (Carsbad, US). The FDA issued a Cleared decision on January 16, 1991 after a review of 149 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - the FDA general and plastic surgery device 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Smith and Nephew Donjoy, Inc. devices

Submission Details

510(k) Number K903823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1990
Decision Date January 16, 1991
Days to Decision 149 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 114d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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.