Cleared Traditional

K871924 - STERILIZATION TRAY

K871924 is an FDA 510(k) clearance for STERILIZATION TRAY, manufactured by Arthropedics, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FSM cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K871924 · Arthropedics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
14d
Days
Class 1
Risk

K871924 is an FDA 510(k) clearance for the STERILIZATION TRAY, TMJ INSTRUMENT SET. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by Arthropedics, Inc. (Wallington, US). The FDA issued a Cleared decision on June 1, 1987 after a review of 14 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 Arthropedics, Inc. devices

FDA 510(k) Submission Details - K871924

510(k) Number K871924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1987
Decision Date June 01, 1987
Days to Decision 14 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
101d faster than avg
Panel avg: 115d · This submission: 14d
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 21
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K871924.
HEART CATH TRAY
K912052 · Medical Device Inspection Co., Inc. · Aug 1991
MAJOR BASIN TRAY
K912104 · Medical Device Inspection Co., Inc. · Aug 1991
STERILE LACERATION TRAY CAT. #749
K900479 · Busse Hospital Disposables, Inc. · Feb 1990
MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY
K870892 · Medsurg Industries, Inc. · Apr 1987
VENESECTION TRAY, ADULT 6050
K843627 · Pro-Lab, Inc. · Dec 1984
HANDI-TRAY
K823438 · Treace Medical, Inc. · Jan 1983