Cleared Traditional

K803119 - LARGE WOUND DRESSING KIT

K803119 is the FDA 510(k) clearance for LARGE WOUND DRESSING KIT by American Medical Disposable, Inc.. It is a Class 1 General & Plastic Surgery device (product code KDD) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K803119 · American Medical Disposable, Inc. · General & Plastic Surgery device
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Dec 1980
Decision
20d
Days
Class 1
Risk

K803119 is an FDA 510(k) clearance for the LARGE WOUND DRESSING KIT. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by American Medical Disposable, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1980 after a review of 20 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 American Medical Disposable, Inc. devices

Submission Details

510(k) Number K803119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1980
Decision Date December 30, 1980
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KDD Kit, Surgical Instrument, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - KDD Kit, Surgical Instrument, Disposable

All 16
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K803119.
STERILE SUTURE BOOTS
K834135 · Devon Industries, Inc. · Apr 1984
FIRST AID KITS
K831795 · I M, Inc. · Sep 1983
ACKRAD INCISION & DRAIN SET
K813103 · Ackrad Laboratories · Dec 1981
CUSTOM DRESSING TRAY WET TO DRY
K803117 · American Medical Disposable, Inc. · Dec 1980
SIMPLE DRESSING TRAY #82028
K803118 · American Medical Disposable, Inc. · Dec 1980
EMERGENCY DEPARTMENT LACERATION KIT-
K802557 · Johnson & Johnson Professionals, Inc. · Nov 1980