Cleared Traditional

K803118 - SIMPLE DRESSING TRAY #82028

K803118 is an FDA 510(k) clearance for SIMPLE DRESSING TRAY #82028, manufactured by American Medical Disposable, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K803118 · American Medical Disposable, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1980
Decision
12d
Days
Class 1
Risk

K803118 is an FDA 510(k) clearance for the SIMPLE DRESSING TRAY #82028. 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 22, 1980 after a review of 12 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

FDA 510(k) Submission Details - K803118

510(k) Number K803118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1980
Decision Date December 22, 1980
Days to Decision 12 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
103d faster than avg
Panel avg: 115d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

KDD Device Classification - Class 1, General Controls

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 20
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K803118.
ACKRAD INCISION & DRAIN SET
K813103 · Ackrad Laboratories · Dec 1981
LARGE WOUND DRESSING KIT
K803119 · American Medical Disposable, Inc. · Dec 1980
CUSTOM DRESSING TRAY WET TO DRY
K803117 · American Medical Disposable, Inc. · Dec 1980
EMERGENCY DEPARTMENT LACERATION KIT-
K802557 · Johnson & Johnson Professionals, Inc. · Nov 1980
DRESSING CHANGE SET CAT.#910-930
K802017 · Pollak (Intl.), Ltd. · Oct 1980
SUTURE REMOVAL SET CAT.#906
K802019 · Pollak (Intl.), Ltd. · Sep 1980