Cleared Traditional

HERMAL WOUND CARE KIT (K895817) - 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.

View all Stiefel Research Institute, Inc. devices

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
3d faster than avg
Panel avg: 115d · 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.

Regulatory Peers - NAD Dressing, Wound, Occlusive

All 9
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K895817.
MEDLINE STERILE GAUZE SPONGES
K930697 · Medline Industries, Inc. · Jun 1993
TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X
K890354 · 3M Company · Apr 1989
3M WOUND CONTACT MATERIAL, PRODUCT #563X
K881988 · 3M Company · Jun 1988
TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING
K872988 · Smith & Nephew, Inc. · Sep 1987
JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSING
K872982 · Johnson & Johnson Professionals, Inc. · Aug 1987
ALLEVYN HYDROPHILIC POLYURETHANE DRESSING
K871166 · Smith & Nephew, Inc. · Jun 1987