Product code DXG— Cardiovascular
CARDIAC OUTPUT COMPUTER
- Classification name
- Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class 2
- Regulation
- 21 CFR 870.1435
- Advisory panel
- Cardiovascular
- Total cleared
- 177
- First cleared
- Most recent
Market context for product code DXG
FDA has cleared devices under product code DXG between 1976 and 2026, filed by 106 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2023
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
Top applicants under product code DXG
Recent clearances under product code DXG
1–100 of 177- K253092 — Argos Infinity (Rev. 1.0)
- K251275 — VitalStream ART Connect; VitalStream-Hemo
- K232048 — Cogent Hemodynamic Monitoring System; Cogent HMS
- K212529 — Hypotension Decision Assist Model HDA-OR2
- K192169 — PulsioFlex Monitoring System with ProAQT Sensor
- K193179 — EV1000 Clinical Platform
- K190955 — Hypotension Decision Assist
- K181372 — Argos
- K172259 — PulsioFlex Monitoring System
- K163334 — LiDCOunity v2 Hemodynamic Monitor
- K152935 — LiDCOunity Monitor
- K134051 — TRANSONIC ELSA SYSTEM
- K134035 — TRANSONIC HCM 103 SYSTEM
- K140017 — TRANSONIC HCM 102 SYSTEM
- K132892 — TEBCO-W
- K131588 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR
- K131892 — EV1000 CLINICAL PLATFORM
- K132528 — E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES
- K122400 — CARDIOX FLOW DETECTION SYSTEM
- K131048 — LIDCO CNAP MODULE
- K122247 — LIDCORAPID V2 MONITOR
- K113821 — TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
- K122121 — PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
- K112448 — PULSIOFLEX
- K110597 — EV1000 CLINICAL PLATFORM
- K103094 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR
- K100709 — EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
- K101487 — CHEETAH NICOM SYSTEM
- K091786 — PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)
- K092219 — NAVIGATOR CLINICAL GUIDENCE SYSTEM
- K082308 — MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
- K080116 — TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
- K081776 — CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM
- K071631 — NICOM ELECTRODES
- K073113 — INFINITY PICCO POD, MODEL MS16734
- K072735 — PULSION PICCO-2, MODEL 8500
- K062134 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
- K060898 — PULSION PICCO PLUS, MODEL 8100
- K060660 — EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER
- K043103 — VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2
- K042144 — NICOM
- K040287 — VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR
- K032997 — MODIFICATION TO: HORIZON 9000WS
- K023960 — LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70
- K021874 — ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711
- K010049 — PULSECO HEMODYNAMIC MONITOR CM71
- K000664 — VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
- K001762 — PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM
- K991775 — MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS
- K962918 — LIDCO SYSTEM
- K970784 — ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T)
- K961661 — OXIMETRIX 4 COMPUTER SYSTEM
- K962128 — TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)
- K955417 — VITAL PAK
- K946115 — EK-VIEW(TM) ECG MANAGEMENT SYSTEM
- K940415 — HORIZON 9000 WS
- K943256 — CARDIAC OUTPUT OPTION 39
- K932414 — CONTINUOUS CARDIAC OUTPUT SYSTEM
- K922218 — IQ SYSTEM
- K913358 — MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST
- K902628 — INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT
- K896930 — CARDIAC OUTPUT COMPUTER, MODEL COM-3
- K901926 — SORBA MODEL CIC-1000 W/NEW ELECTRODES
- K895017 — SORBA MODEL CIC-1000, COMP. IMPEDANCE CARDIOGRAPH
- K897004 — NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM
- K896528 — SFA MODULE
- K894234 — SENSOCOR TM R-TEST 24OXL
- K893392 — CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER
- K884122 — TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA
- K884619 — PACH-PEN CALCULATOR
- K883855 — PREDICTOR II SIGNAL AVERAGING ECG
- K880301 — 3000 PHYSIOLOGICAL MONITOR
- K880258 — WITT BIOMEDICAL VX-80
- K880696 — MX1002 CABLE-CAL TM
- K875167 — HORIZON 9000
- K872529 — THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2
- K870375 — MODEL 617 CARDIAC OUTPUT COMPUTER
- K871659 — IMS-2000S STRESS MONITOR
- K870934 — IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM
- K865101 — SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM
- K861505 — HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER
- K861543 — CARDIOMAX-II
- K854371 — MTC 6210A CARDIAC OUTPUT COMPUTER
- K862261 — KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263
- K862808 — BIOMA 2000
- K863153 — MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH
- K863308 — 2200I PHYSIOLOGICAL MONITOR
- K863230 — D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM
- K863231 — D100 COMPUTER CARDIAC ANALYSIS SYSTEM
- K861092 — MODEL SP1465 CARDIAC OUTPUT COMPUTER
- K861437 — QMED SYSTEM 2150
- K860015 — MODIFIED CHERNE CAD DETECTOR
- K853018 — MODEL 3000 OPTICATH COMPUTER
- K854136 — ARRHYTHMIA REVIEW STATION
- K852900 — CVERNE CAD DETECTOR
- K841967 — DESERET THERMODILUTION CARDIAC OUTPUT
- K834059 — FUKUDA DENSHI EH-11
- K844116 — CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC
- K844997 — IAI PROGRAM-COMPUTER PROGRAM
- K850568 — MODEL 78231D CARDIAC OUTPUT MODULE
Data sourced from openFDA. This site is unofficial and independent of the FDA.