Cleared Traditional

K895817 - HERMAL WOUND CARE KIT (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K895817 · Stiefel Research Institute, Inc. · General & Plastic Surgery device
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Jan 1990
Decision
112d
Days
Class 1
Risk

K895817 is an FDA 510(k) clearance for the HERMAL WOUND CARE KIT. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Stiefel Research Institute, Inc. (Oakhill, US). The FDA issued a Cleared decision on January 19, 1990 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - 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.

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Submission Details

510(k) Number K895817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1989
Decision Date January 19, 1990
Days to Decision 112 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
2d faster than avg
Panel avg: 114d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
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.