Cleared Traditional

K852211 - OPSITE WOUND DRESSING

K852211 is an FDA 510(k) clearance for OPSITE WOUND DRESSING, manufactured by Smith & Nephew, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K852211 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1985
Decision
63d
Days
Class 1
Risk

K852211 is an FDA 510(k) clearance for the OPSITE WOUND 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 July 23, 1985 after a review of 63 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.

FDA 510(k) Submission Details - K852211

510(k) Number K852211 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 21, 1985
Decision Date July 23, 1985
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

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 107
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K852211.
PRIMADERM
K854740 · Absorbent Cotton Co., Inc. · Mar 1986
FALKON STRETCH-STERILE
K854850 · G.B.F. Industries, Inc. · Jan 1986
NON-ADHERA ADHESIVE PAD 3X4
K853334 · American White Cross, Inc. · Aug 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
ALBA DRY BURN PAD
K852091 · Alba-Waldensian, Inc. · Jun 1985
K852211 · OPSITE WOUND DRESSING
Download PDF Smith & Nephew, Inc.