Cleared Traditional

K863231 - D100 COMPUTER CARDIAC ANALYSIS SYSTEM

K863231 is an FDA 510(k) clearance for D100 COMPUTER CARDIAC ANALYSIS SYSTEM, manufactured by Dextra Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K863231 · Dextra Medical, Inc. · Cardiovascular device
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Nov 1986
Decision
96d
Days
Class 2
Risk

K863231 is an FDA 510(k) clearance for the D100 COMPUTER CARDIAC ANALYSIS SYSTEM. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Dextra Medical, Inc. (Long Beach, US). The FDA issued a Cleared decision on November 25, 1986 after a review of 96 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 Dextra Medical, Inc. devices

FDA 510(k) Submission Details - K863231

510(k) Number K863231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1986
Decision Date November 25, 1986
Days to Decision 96 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 125d · This submission: 96d
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 K863231.
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2200I PHYSIOLOGICAL MONITOR
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MODEL SP1465 CARDIAC OUTPUT COMPUTER
K861092 · Gould, Inc. · Aug 1986
ARRHYTHMIA REVIEW STATION
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DESERET THERMODILUTION CARDIAC OUTPUT
K841967 · Parke-Davis Co. · Aug 1985