Cleared Traditional

K925583 - JOBSKIN CONTINUING CARE (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K925583 · Jobst Institute, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 1994
Decision
515d
Days
Class 1
Risk

K925583 is an FDA 510(k) clearance for the JOBSKIN CONTINUING CARE. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Jobst Institute, Inc. (Toledo, US). The FDA issued a Cleared decision on April 4, 1994 after a review of 515 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4025 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Jobst Institute, Inc. devices

Submission Details

510(k) Number K925583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1992
Decision Date April 04, 1994
Days to Decision 515 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
401d slower than avg
Panel avg: 114d · This submission: 515d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MDA Elastomer, Silicone, For Scar Management
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4025
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.