Cleared Traditional

K896930 - CARDIAC OUTPUT COMPUTER

K896930 is the FDA 510(k) clearance for CARDIAC OUTPUT COMPUTER by Baxter Healthcare Corp. It is a Class 2 Cardiovascular device (product code DXG) cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K896930 · Baxter Healthcare Corp · Cardiovascular device
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Jul 1990
Decision
204d
Days
Class 2
Risk

K896930 is an FDA 510(k) clearance for the CARDIAC OUTPUT COMPUTER, MODEL COM-3. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on July 3, 1990 after a review of 204 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K896930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1989
Decision Date July 03, 1990
Days to Decision 204 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
79d slower than avg
Panel avg: 125d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 84
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K896930.
VITAL PAK
K955417 · Vital Signs, Inc. · Mar 1996
HORIZON 9000 WS
K940415 · Mennen Medical, Inc. · Jan 1995
CONTINUOUS CARDIAC OUTPUT SYSTEM
K932414 · Abbott Laboratories · Nov 1994
NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM
K897004 · Advanced Technology Laboratories, Inc. · Mar 1990
CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER
K893392 · Baxter Healthcare Corp · Jun 1989
TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA
K884122 · S & W Medico Teknik · Apr 1989