DXG · Class II · 21 CFR 870.1435

FDA Product Code DXG: Computer, Diagnostic, Pre-programmed, Single-function

Leading manufacturers include Hewlett-Packard Co., Abbott Laboratories and Baxter Healthcare Corp.

177
Total
177
Cleared
130d
Avg days
1976
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Consistent review times: 149d avg (recent)

FDA 510(k) Cleared Computer, Diagnostic, Pre-programmed, Single-function Devices (Product Code DXG)

177 devices
1–24 of 177
Cleared Feb 13, 2026
Argos Infinity (Rev. 1.0)
K253092
Retia Medical Systems, Inc.
Cardiovascular · 143d
Cleared Sep 26, 2025
VitalStream ART Connect
K251275
Caretaker Medical
Cardiovascular · 155d
Cleared Dec 20, 2023
Cogent™ Hemodynamic Monitoring System
K232048
Icu Medical
Cardiovascular · 163d
Cleared Nov 23, 2021
Hypotension Decision Assist Model HDA-OR2
K212529
Directed Systems, Ltd.
Cardiovascular · 104d
Cleared Apr 30, 2020
PulsioFlex Monitoring System with ProAQT Sensor
K192169
Pulsion Medical Systems SE
Cardiovascular · 265d
Cleared Dec 17, 2019
EV1000 Clinical Platform
K193179
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Nov 27, 2019
Hypotension Decision Assist
K190955
Directed Systems, Ltd.
Cardiovascular · 230d
Cleared Dec 13, 2018
Argos
K181372
Retia Medical, LLC
Cardiovascular · 204d
Cleared Jan 18, 2018
PulsioFlex Monitoring System
K172259
Pulsion Medical Systems SE
Cardiovascular · 175d
Cleared Jul 12, 2002
ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711
K021874
Abbott Laboratories
Cardiovascular · 35d
Cleared Sep 20, 2000
VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
K000664
Baxter Healthcare Corp
Cardiovascular · 205d
Cleared Mar 04, 1997
OXIMETRIX 4 COMPUTER SYSTEM
K961661
Abbott Laboratories
Cardiovascular · 308d
Cleared Nov 14, 1994
CONTINUOUS CARDIAC OUTPUT SYSTEM
K932414
Abbott Laboratories
Cardiovascular · 544d
Cleared Jul 03, 1990
CARDIAC OUTPUT COMPUTER, MODEL COM-3
K896930
Baxter Healthcare Corp
Cardiovascular · 204d
Cleared Jun 20, 1989
CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER
K893392
Baxter Healthcare Corp
Cardiovascular · 50d
Cleared Apr 09, 1985
MODEL 78231D CARDIAC OUTPUT MODULE
K850568
Hewlett-Packard Co.
Cardiovascular · 56d
Cleared Oct 02, 1984
MODELS 78551A 78552A
K841256
Hewlett-Packard Co.
Cardiovascular · 214d
Cleared Mar 22, 1984
HEMODYNAMIC PLUG-IN MODULE 78551A
K833913
Hewlett-Packard Co.
Cardiovascular · 129d
Cleared Mar 22, 1984
CARDIAC OUTPUT SIGNAL ACQUISTION
K833914
Hewlett-Packard Co.
Cardiovascular · 129d
Cleared Nov 01, 1982
IL 801 THERMALDILUTION CARDIAC OUTPUT
K822972
Instrumentation Laboratory CO
Cardiovascular · 24d
Cleared Oct 18, 1982
MODEL 78554A DATA MGMT. PLUG-IN MODULE
K822877
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Nov 26, 1980
PDS THERMAL DILUTION CARDIAC MODULE(OUT)
K802316
General Electric Co.
Cardiovascular · 64d
Cleared Nov 03, 1977
CARDIAC OUTPUT THERMODILUTION MODULE
K771991
Abbott Laboratories
Cardiovascular · 15d
Cleared Apr 05, 1977
CARDIAC CATHETERIZATION LAB MONITOR SYS
K770179
General Electric Co.
Cardiovascular · 68d

About Product Code DXG - Regulatory Context

510(k) Submission Activity

177 total 510(k) submissions under product code DXG since 1976, with 177 receiving FDA clearance (average review time: 130 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DXG Product Code

FDA review times for DXG submissions have been consistent, averaging 149 days recently vs 130 days historically.

DXG devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →