Cleared Traditional

K851382 - CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING

K851382 is an FDA 510(k) clearance for CHESEBROUGH-POND'S SEQUENTIAL WOUND DRE..., manufactured by Chesebrough-Pond'S U.S.A. Co.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K851382 · Chesebrough-Pond'S U.S.A. Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1985
Decision
88d
Days
Class 1
Risk

K851382 is an FDA 510(k) clearance for the CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING. 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 July 5, 1985 after a review of 88 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 Chesebrough-Pond'S U.S.A. Co. devices

FDA 510(k) Submission Details - K851382

510(k) Number K851382 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 08, 1985
Decision Date July 05, 1985
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 45
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K851382.
WOUND MANAGER(TM) - STERILE
K862935 · Convatec, A Division of E.R. Squibb & Sons · Aug 1986
LYOFOAM WOUND DRESSINGS
K860085 · Acme United Corp. · Jun 1986
OPSITE WOUND DRESSING
K852211 · Smith & Nephew, Inc. · Jul 1985
BLISTERFILM TRANSPARENT DRESSING
K851383 · Chesebrough-Pond'S U.S.A. Co. · Jul 1985
HYPAFIX POST OPERATIVE DRESSING
K850282 · Smith & Nephew, Inc. · May 1985
ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND
K843139 · Chesebrough-Pond'S U.S.A. Co. · Nov 1984