Cleared Traditional

DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC (K951064) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K951064 · S-E Sales & Distribution, Inc. · General & Plastic Surgery device
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May 1995
Decision
72d
Days
Class 1
Risk

K951064 is an FDA 510(k) clearance for the DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC. Classified as Tape, Measuring, Rulers And Calipers (product code FTY), Class I - General Controls.

Submitted by S-E Sales & Distribution, Inc. (Poultney, US). The FDA issued a Cleared decision on May 19, 1995 after a review of 72 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 S-E Sales & Distribution, Inc. devices

Submission Details

510(k) Number K951064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1995
Decision Date May 19, 1995
Days to Decision 72 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
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FTY Tape, Measuring, Rulers And Calipers
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.