Cleared Traditional

PADGETT AIR DERMATOME, MODEL A (K951085) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K951085 · Padgett Instruments, Inc. · General & Plastic Surgery device
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May 1995
Decision
67d
Days
Class 1
Risk

K951085 is an FDA 510(k) clearance for the PADGETT AIR DERMATOME, MODEL A. Classified as Dermatome (product code GFD), Class I - General Controls.

Submitted by Padgett Instruments, Inc. (Kansas City, US). The FDA issued a Cleared decision on May 15, 1995 after a review of 67 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - 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 Padgett Instruments, Inc. devices

Submission Details

510(k) Number K951085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1995
Decision Date May 15, 1995
Days to Decision 67 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
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GFD Dermatome
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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.