Cleared Traditional

K831407 - CARDIAC OUTPUT COMPUTER

K831407 is an FDA 510(k) clearance for CARDIAC OUTPUT COMPUTER, manufactured by Ziehm International, Inc.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K831407 · Ziehm International, Inc. · Cardiovascular device
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Oct 1983
Decision
165d
Days
Class 2
Risk

K831407 is an FDA 510(k) clearance for the CARDIAC OUTPUT COMPUTER. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Ziehm International, Inc. (Annapolis, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 165 days - an extended review cycle.

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 Ziehm International, Inc. devices

FDA 510(k) Submission Details - K831407

510(k) Number K831407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1983
Decision Date October 14, 1983
Days to Decision 165 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 125d · This submission: 165d
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 115
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K831407.
CARDIAC OUTPUT SIGNAL ACQUISTION
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CRITIKON CARDIAC OUTPUT COMPUTER
K831967 · Critikon Company, LLC · Oct 1983
THERMODILUTION CARDIAC OUTPUT COMPUTER-
K830892 · American Edwards Laboratories · Jun 1983
AUTOECHO
K822903 · Oxford Medilog, Inc. · Nov 1982
IL 801 THERMALDILUTION CARDIAC OUTPUT
K822972 · Instrumentation Laboratory CO · Nov 1982