Cleared Traditional

K844095 - WET DRESSING WATER-STERILE

K844095 is an FDA 510(k) clearance for WET DRESSING WATER-STERILE, manufactured by Absorbent Cotton Co., Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K844095 · Absorbent Cotton Co., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
35d
Days
Class 1
Risk

K844095 is an FDA 510(k) clearance for the WET DRESSING WATER-STERILE. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Absorbent Cotton Co., Inc. (Hammonton, US). The FDA issued a Cleared decision on November 27, 1984 after a review of 35 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 Absorbent Cotton Co., Inc. devices

FDA 510(k) Submission Details - K844095

510(k) Number K844095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1984
Decision Date November 27, 1984
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
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 56
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K844095.
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
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
ISOLATE ADHESIVE BANDAGE FOR DRY WOUND
K843140 · Chesebrough-Pond'S U.S.A. Co. · Nov 1984
ACU-DERM TRANSPARENT WOUND DRESSING
K842186 · Acme United Corp. · Aug 1984