Cleared Traditional

K894254 - HYPAFIX DRESSING RETENTION SHEET

K894254 is the FDA 510(k) clearance for HYPAFIX DRESSING RETENTION SHEET by Smith & Nephew United, Inc.. It is a Class 1 General & Plastic Surgery device (product code NAD) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K894254 · Smith & Nephew United, Inc. · General & Plastic Surgery device
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Aug 1989
Decision
72d
Days
Class 1
Risk

K894254 is an FDA 510(k) clearance for the HYPAFIX DRESSING RETENTION SHEET. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on August 31, 1989 after a review of 72 days - a notably fast clearance cycle.

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: 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 Smith & Nephew United, Inc. devices

Submission Details

510(k) Number K894254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1989
Decision Date August 31, 1989
Days to Decision 72 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
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 35
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K894254.
MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS
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TENSOPLUS LITE
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2018 ARTERIAL/VENOUS PRESSURE DRESSING
K895845 · Advance Medical Designs, Inc. · Nov 1989
DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFY
K892527 · Convatec, A Division of E.R. Squibb & Sons · May 1989
DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING
K891696 · Convatec, A Division of E.R. Squibb & Sons · May 1989
TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X
K890354 · 3M Company · Apr 1989