Cleared Traditional

K935705 - ALLEVYN ISLAND WOUND DRESSING

K935705 is an FDA 510(k) clearance for ALLEVYN ISLAND WOUND DRESSING, manufactured by Smith & Nephew United, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAE cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K935705 · Smith & Nephew United, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Feb 1994
Decision
77d
Days
Class 1
Risk

K935705 is an FDA 510(k) clearance for the ALLEVYN ISLAND WOUND DRESSING. Classified as Dressing, Wound, Hydrogel Without Drug And/or Biologic (product code NAE), Class I - General Controls.

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on February 15, 1994 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4022 - 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.

FDA 510(k) Submission Details - K935705

510(k) Number K935705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1993
Decision Date February 15, 1994
Days to Decision 77 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

NAE Device Classification - Class 1, General Controls

Product Code NAE Dressing, Wound, Hydrogel Without Drug And/or Biologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4022
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 - NAE Dressing, Wound, Hydrogel Without Drug And/or Biologic

All 28
Devices cleared under the same product code (NAE) and FDA review panel - the closest regulatory comparables to K935705.
INTRASITE
K942748 · Smith & Nephew United, Inc. · Jun 1994
BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING
K941019 · Brady Medical Products Co. · May 1994
NDM HYDROGAUZE WOUND DRESSING
K934601 · Ndm Acquisition Corp. · Feb 1994
BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING
K935848 · Brady Medical Products Co. · Feb 1994
NU-GEL ISLAND WOUND DRESSING
K932336 · Johnson & Johnson Medical, Inc. · Feb 1994
DUODERM HYDROCOLLOID GEL
K931618 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993
K935705 · ALLEVYN ISLAND WOUND DRESSING
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