Cleared Traditional

K912053 - OPEN HEART TRAY

K912053 is an FDA 510(k) clearance for OPEN HEART TRAY, manufactured by Medical Device Inspection Co., Inc.. The device is a Class 1 General & Plastic Surgery device with product code FSM cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K912053 · Medical Device Inspection Co., Inc. · General & Plastic Surgery device
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Aug 1991
Decision
109d
Days
Class 1
Risk

K912053 is an FDA 510(k) clearance for the OPEN HEART 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 26, 1991 after a review of 109 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

FDA 510(k) Submission Details - K912053

510(k) Number K912053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1991
Decision Date August 26, 1991
Days to Decision 109 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
6d faster than avg
Panel avg: 115d · This submission: 109d
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 38
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K912053.
INSTRUMENT TRAY LINER
K971217 · General Hospital Supply Corp. · May 1997
SINGLE USE INSTRUMENT TRAY
K962328 · Medcare Medical Group, Inc. · Aug 1996
ARTHROSCOPY TRAY
K912106 · 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
HAND SURGERY AND IRRIGATION TRAY (MODEL 3625)
K900376 · Pmt Corp. · Apr 1990