Cleared Traditional

K843723 - STERILE INSTRUMENT TRAYS-VARIOUS

K843723 is an FDA 510(k) clearance for STERILE INSTRUMENT TRAYS-VARIOUS, manufactured by E.M. Adams. The device is a Class 1 General & Plastic Surgery device with product code FSM cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K843723 · E.M. Adams · General & Plastic Surgery device
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Oct 1984
Decision
29d
Days
Class 1
Risk

K843723 is an FDA 510(k) clearance for the STERILE INSTRUMENT TRAYS-VARIOUS. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by E.M. Adams (Medfield, US). The FDA issued a Cleared decision on October 23, 1984 after a review of 29 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 E.M. Adams devices

FDA 510(k) Submission Details - K843723

510(k) Number K843723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1984
Decision Date October 23, 1984
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

FSM Device Classification - Class 1, General Controls

Product Code FSM Tray, Surgical, Instrument
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 - FSM Tray, Surgical, Instrument

All 24
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K843723.
STERILIZATION TRAY, TMJ INSTRUMENT SET
K871924 · Arthropedics, Inc. · Jun 1987
MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY
K870892 · Medsurg Industries, Inc. · Apr 1987
VENESECTION TRAY, ADULT 6050
K843627 · Pro-Lab, Inc. · Dec 1984
VARIOUS DISPOSABLE KITS/TRAYS/INSTRU
K840976 · Carapace, Inc. · May 1984
HANDI-TRAY
K823438 · Treace Medical, Inc. · Jan 1983
OPERATING ROOM KIT
K811916 · American Hospital Supply Corp. · Oct 1981