Cleared Traditional

K832644 - ALPHA CARDIAC OUTPUT CARDULE #1899

K832644 is an FDA 510(k) clearance for ALPHA CARDIAC OUTPUT CARDULE #1899, manufactured by Spacelabs, Inc.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K832644 · Spacelabs, Inc. · Cardiovascular device
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Jan 1984
Decision
175d
Days
Class 2
Risk

K832644 is an FDA 510(k) clearance for the ALPHA CARDIAC OUTPUT CARDULE #1899. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Spacelabs, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 27, 1984 after a review of 175 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 Spacelabs, Inc. devices

FDA 510(k) Submission Details - K832644

510(k) Number K832644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1983
Decision Date January 27, 1984
Days to Decision 175 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
50d slower than avg
Panel avg: 125d · This submission: 175d
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 85
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K832644.
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HEMODYNAMIC PLUG-IN MODULE 78551A
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CARDIAC OUTPUT SIGNAL ACQUISTION
K833914 · Hewlett-Packard Co. · Mar 1984
CRITIKON CARDIAC OUTPUT COMPUTER
K831967 · Critikon Company, LLC · Oct 1983
THERMODILUTION CARDIAC OUTPUT COMPUTER-
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AUTOECHO
K822903 · Oxford Medilog, Inc. · Nov 1982