Cleared Traditional

K850282 - HYPAFIX POST OPERATIVE DRESSING

K850282 is the FDA 510(k) clearance for HYPAFIX POST OPERATIVE DRESSING by Smith & Nephew, Inc.. It is a Class 1 General & Plastic Surgery device (product code NAD) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K850282 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
104d
Days
Class 1
Risk

K850282 is an FDA 510(k) clearance for the HYPAFIX POST OPERATIVE DRESSING. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Smith & Nephew, Inc. (Columbia, US). The FDA issued a Cleared decision on May 7, 1985 after a review of 104 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K850282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1985
Decision Date May 07, 1985
Days to Decision 104 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
11d faster than avg
Panel avg: 115d · This submission: 104d
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 34
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K850282.
OPSITE WOUND DRESSING
K852211 · Smith & Nephew, Inc. · Jul 1985
CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING
K851382 · Chesebrough-Pond'S U.S.A. Co. · Jul 1985
BLISTERFILM TRANSPARENT DRESSING
K851383 · Chesebrough-Pond'S U.S.A. Co. · Jul 1985
ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND
K843139 · Chesebrough-Pond'S U.S.A. Co. · Nov 1984
ISOLATE ADHESIVE BANDAGE FOR DRY WOUND
K843140 · Chesebrough-Pond'S U.S.A. Co. · Nov 1984
ELASTIC BREATHABLE OVER-WRAP BANDAGE
K833729 · American Medical Disposable, Inc. · Dec 1983