Cleared Traditional

K863153 - MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH

K863153 is an FDA 510(k) clearance for MODIFICATION OF CARDIOINTEGRAM/CARDIOIN..., manufactured by Ocg Technology, Inc.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K863153 · Ocg Technology, Inc. · Cardiovascular device
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Jan 1987
Decision
144d
Days
Class 2
Risk

K863153 is an FDA 510(k) clearance for the MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Ocg Technology, Inc. (Farmingdale, US). The FDA issued a Cleared decision on January 6, 1987 after a review of 144 days - within the typical 510(k) review window.

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. 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 Ocg Technology, Inc. devices

FDA 510(k) Submission Details - K863153

510(k) Number K863153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1986
Decision Date January 06, 1987
Days to Decision 144 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 125d · This submission: 144d
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 117
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K863153.
THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2
K872529 · American Edwards Laboratories · Sep 1987
MTC 6210A CARDIAC OUTPUT COMPUTER
K854371 · Nihon Kohden America, Inc. · Feb 1987
KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263
K862261 · Kontron Instruments, Inc. · Feb 1987
2200I PHYSIOLOGICAL MONITOR
K863308 · Datascope Corp. · Jan 1987
MODEL SP1465 CARDIAC OUTPUT COMPUTER
K861092 · Gould, Inc. · Aug 1986
ARRHYTHMIA REVIEW STATION
K854136 · Marquette Electronics, Inc. · Dec 1985