Cleared Traditional

K912104 - MAJOR BASIN TRAY

K912104 is the FDA 510(k) clearance for MAJOR BASIN 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 88-day FDA review.

K912104 · Medical Device Inspection Co., Inc. · General & Plastic Surgery device
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Aug 1991
Decision
88d
Days
Class 1
Risk

K912104 is an FDA 510(k) clearance for the MAJOR BASIN 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 9, 1991 after a review of 88 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 Medical Device Inspection Co., Inc. devices

Submission Details

510(k) Number K912104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1991
Decision Date August 09, 1991
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 K912104.
ARTHROSCOPY TRAY
K912106 · Medical Device Inspection Co., Inc. · Aug 1991
OPEN HEART TRAY
K912053 · Medical Device Inspection Co., Inc. · Aug 1991
HEART CATH TRAY
K912052 · 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