Cleared Traditional

K901072 - CENTRALSCOPE 12

K901072 is an FDA 510(k) clearance for CENTRALSCOPE 12, manufactured by Marquette Electronics, Inc.. The device is a Class 2 Cardiovascular device with product code DXJ cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K901072 · Marquette Electronics, Inc. · Cardiovascular device
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Aug 1990
Decision
169d
Days
Class 2
Risk

K901072 is an FDA 510(k) clearance for the CENTRALSCOPE 12. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on August 23, 1990 after a review of 169 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2450 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Marquette Electronics, Inc. devices

FDA 510(k) Submission Details - K901072

510(k) Number K901072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1990
Decision Date August 23, 1990
Days to Decision 169 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 125d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXJ Device Classification - Class 2, Special Controls

Product Code DXJ Display, Cathode-ray Tube, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXJ Display, Cathode-ray Tube, Medical

All 65
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K901072.
HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATOR
K945277 · Hewlett-Packard Co. · Jan 1995
SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY
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MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM
K905788 · Hewlett-Packard Co. · Jun 1991
7620 REMOTE CENTRAL STATION REPEATER
K901884 · Marquette Electronics, Inc. · Jun 1990
HORIZON DISPLAY CONTROLLER PART # 266-200-010
K884423 · Mennen Medical, Inc. · May 1989
MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A
K883973 · Nihon Kohden America, Inc. · Nov 1988