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 Lidco, Ltd..

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 Jun 05, 2017
LiDCOunity v2 Hemodynamic Monitor
K163334
Lidco, Ltd.
Cardiovascular · 189d
Cleared Mar 17, 2016
LiDCOunity Monitor
K152935
Lidco, Ltd.
Cardiovascular · 164d
Cleared Jan 29, 2015
TRANSONIC ELSA SYSTEM
K134051
Transonic Systems, Inc.
Cardiovascular · 394d
Cleared Sep 17, 2014
TRANSONIC HCM 103 SYSTEM
K134035
Transonic Systems, Inc.
Cardiovascular · 260d
Cleared Sep 16, 2014
TRANSONIC HCM 102 SYSTEM
K140017
Transonic Systems, Inc.
Cardiovascular · 257d
Cleared Aug 01, 2014
TEBCO-W
K132892
Bomed, Inc.
Cardiovascular · 319d
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 Jan 16, 2014
E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES
K132528
GE Healthcare Finland Oy
Cardiovascular · 157d
Cleared Nov 05, 2013
CARDIOX FLOW DETECTION SYSTEM
K122400
Cardiox Corp.
Cardiovascular · 455d
Cleared Aug 28, 2013
LIDCO CNAP MODULE
K131048
Lidco, Ltd.
Cardiovascular · 135d
Cleared Mar 20, 2013
LIDCORAPID V2 MONITOR
K122247
Lidco, Ltd.
Cardiovascular · 236d
Cleared Sep 07, 2012
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
K113821
Transonic Systems, Inc.
Cardiovascular · 255d
Cleared Aug 02, 2012
PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
K122121
Pulsion Medical Systems SE
Cardiovascular · 16d
Cleared Sep 22, 2011
PULSIOFLEX
K112448
Pulsion Medical Systems, Inc.
Cardiovascular · 28d

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 →