Cleared Traditional

K861543 - CARDIOMAX-II

K861543 is an FDA 510(k) clearance for CARDIOMAX-II, manufactured by Columbus Instruments Intl. Corp.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 320-day FDA review.

K861543 · Columbus Instruments Intl. Corp. · Cardiovascular device
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Mar 1987
Decision
320d
Days
Class 2
Risk

K861543 is an FDA 510(k) clearance for the CARDIOMAX-II. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Columbus Instruments Intl. Corp. (Columbus, US). The FDA issued a Cleared decision on March 10, 1987 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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. Elevated predicate reliance profile. 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 Columbus Instruments Intl. Corp. devices

FDA 510(k) Submission Details - K861543

510(k) Number K861543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1986
Decision Date March 10, 1987
Days to Decision 320 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 125d · This submission: 320d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 114
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K861543.
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K863308 · Datascope Corp. · Jan 1987