DXG · Class II · 21 CFR 870.1435

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

Leading manufacturers include Edwards Lifesciences, LLC, Hewlett-Packard Co. and American Edwards Laboratories.

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 May 22, 2014
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
K131588
Edwards Lifesciences, LLC
Cardiovascular · 356d
Cleared May 22, 2014
EV1000 CLINICAL PLATFORM
K131892
Edwards Lifesciences, LLC
Cardiovascular · 331d
Cleared May 17, 2011
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR
K103094
Edwards Lifesciences, LLC
Cardiovascular · 210d
Cleared Dec 07, 2010
EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
K100709
Edwards Lifesciences, LLC
Cardiovascular · 270d
Cleared Dec 09, 2008
MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
K082308
Edwards Lifesciences, LLC
Cardiovascular · 118d
Cleared Jan 03, 2008
INFINITY PICCO POD, MODEL MS16734
K073113
Draeger Medical Systems, Inc.
Cardiovascular · 59d
Cleared Aug 22, 2006
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
K062134
Edwards Lifesciences, LLC
Cardiovascular · 27d
Cleared Apr 25, 2006
EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER
K060660
Edwards Lifesciences, LLC
Cardiovascular · 43d
Cleared Dec 09, 2004
VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2
K043103
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Apr 26, 2004
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR
K040287
Edwards Lifesciences, LLC
Cardiovascular · 80d
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 May 14, 1997
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T)
K970784
Alexander Mfg. Co.
Cardiovascular · 71d
Cleared Mar 04, 1997
OXIMETRIX 4 COMPUTER SYSTEM
K961661
Abbott Laboratories
Cardiovascular · 308d
Cleared Mar 08, 1996
VITAL PAK
K955417
Vital Signs, Inc.
Cardiovascular · 102d

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 →