Cleared Traditional

K843140 - ISOLATE ADHESIVE BANDAGE FOR DRY WOUND

K843140 is the FDA 510(k) clearance for ISOLATE ADHESIVE BANDAGE FOR DRY WOUND by Chesebrough-Pond'S U.S.A. Co.. It is a Class 1 General & Plastic Surgery device (product code NAD) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K843140 · Chesebrough-Pond'S U.S.A. Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
91d
Days
Class 1
Risk

K843140 is an FDA 510(k) clearance for the ISOLATE ADHESIVE BANDAGE FOR DRY WOUND. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Chesebrough-Pond'S U.S.A. Co. (Trumbull, US). The FDA issued a Cleared decision on November 8, 1984 after a review of 91 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 Chesebrough-Pond'S U.S.A. Co. devices

Submission Details

510(k) Number K843140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1984
Decision Date November 08, 1984
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
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 16
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K843140.
WOUND MANAGER(TM) - STERILE
K862935 · Convatec, A Division of E.R. Squibb & Sons · Aug 1986
OPSITE WOUND DRESSING
K852211 · Smith & Nephew, Inc. · Jul 1985
HYPAFIX POST OPERATIVE DRESSING
K850282 · Smith & Nephew, Inc. · May 1985
LASTOBAND ADHESIVE BANDAGES
K831454 · Smith & Nephew, Inc. · Oct 1983
ADHESIVE WOUND COVER FILM
K822080 · Hollister, Inc. · Oct 1982