Cleared Traditional

K944588 - STERILE PLASTIC DRESSING (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K944588 · Smith & Nephew, Inc. · General & Plastic Surgery device
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Nov 1994
Decision
49d
Days
Class 1
Risk

K944588 is an FDA 510(k) clearance for the STERILE PLASTIC DRESSING. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Smith & Nephew, Inc. (Quebec, CA). The FDA issued a Cleared decision on November 7, 1994 after a review of 49 days - a notably fast clearance cycle.

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: 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K944588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1994
Decision Date November 07, 1994
Days to Decision 49 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 114d · This submission: 49d
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.