Cleared Traditional

K912106 - ARTHROSCOPY TRAY

K912106 is the FDA 510(k) clearance for ARTHROSCOPY TRAY by Medical Device Inspection Co., Inc.. It is a Class 1 General & Plastic Surgery device (product code FSM) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K912106 · Medical Device Inspection Co., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
108d
Days
Class 1
Risk

K912106 is an FDA 510(k) clearance for the ARTHROSCOPY TRAY. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on August 29, 1991 after a review of 108 days - within the typical 510(k) review window.

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 Medical Device Inspection Co., Inc. devices

Submission Details

510(k) Number K912106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1991
Decision Date August 29, 1991
Days to Decision 108 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 115d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 16
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K912106.
OPEN HEART TRAY
K912053 · Medical Device Inspection Co., Inc. · Aug 1991
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
HANDI-TRAY
K823438 · Treace Medical, Inc. · Jan 1983