Cleared Traditional

K844096 - WET DRESSING SALINE-STERILE

K844096 · Absorbent Cotton Co., Inc. · General & Plastic Surgery device
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Nov 1984
Decision
27d
Days
-
Risk

K844096 is an FDA 510(k) clearance for the WET DRESSING SALINE-STERILE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Absorbent Cotton Co., Inc. (Hammonton, US). The FDA issued a Cleared decision on November 19, 1984 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 - K844096

510(k) Number K844096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1984
Decision Date November 19, 1984
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 591
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K844096.
CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE
K850147 · Beiersdorf, Inc. · Jul 1985
BARD OCCLUSIVE WOUND DRESSING
K850889 · C.R. Bard, Inc. · Jul 1985
J & J ULCER DRESSING
K850451 · Johnson & Johnson Professionals, Inc. · Jun 1985
AQUAPHOR R GAUZE
K842967 · Beiersdorf, Inc. · Nov 1984
COMFEEL ULCUS SHEET
K840438 · Coloplast A/S · Nov 1984
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
K841287 · Convatec, A Division of E.R. Squibb & Sons · Aug 1984