Cleared Traditional

K831841 - STERILE DISP. INSTRUMENT TRAYS

K831841 is an FDA 510(k) clearance for STERILE DISP. INSTRUMENT TRAYS, manufactured by E.M. Adams. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K831841 · E.M. Adams · General & Plastic Surgery device
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Dec 1983
Decision
190d
Days
Class 1
Risk

K831841 is an FDA 510(k) clearance for the STERILE DISP. INSTRUMENT TRAYS. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by E.M. Adams (Mchenry, US). The FDA issued a Cleared decision on December 14, 1983 after a review of 190 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all E.M. Adams devices

FDA 510(k) Submission Details - K831841

510(k) Number K831841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1983
Decision Date December 14, 1983
Days to Decision 190 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
75d slower than avg
Panel avg: 115d · This submission: 190d
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 26
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K831841.
SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW
K871458 · Fraass Survival Systems, Inc. · Jul 1987
C-SECTION TRAY
K842627 · Deroyal Industries, Inc. · Sep 1984
STERILE SUTURE BOOTS
K834135 · Devon Industries, Inc. · Apr 1984
STERILE SUTURE REMOVAL SET
K832047 · Ormed Mfg., Inc. · Sep 1983
FIRST AID KITS
K831795 · I M, Inc. · Sep 1983
ACKRAD INCISION & DRAIN SET
K813103 · Ackrad Laboratories · Dec 1981