ClearanceBrief
Panels › Cardiovascular › Product code MWI · Class 2

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Regulation 870.2300

6510(k)s in 12 months (309 all time)
11recalls in 12 months (85 all time)
80recalls that name a 510(k)
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Top companies in MWI

DateFirm and productCodeLinked 510(k)
Sep 18, 2026Midmark Corporation
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients
Open, Classified
MWIK161909
Sep 18, 2026Midmark Corporation
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients
Open, Classified
MWIK161909
Sep 18, 2026Midmark Corporation
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients
Open, Classified
MWIK161909
Sep 18, 2026Midmark Corporation
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients
Open, Classified
MWIK161909
Aug 27, 2026GE Medical Systems Information Technologies Inc
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
Open, Classified
MWINone listed
Aug 27, 2026GE Medical Systems Information Technologies Inc
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
Open, Classified
MWIK230626
Aug 27, 2026GE Medical Systems Information Technologies Inc
PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
Open, Classified
MWIK234130
Aug 27, 2026GE Medical Systems Information Technologies Inc
PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
Open, Classified
MWIK234130
Aug 4, 2026GE Medical Systems Information Technologies Inc
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592
Open, Classified
MWIK234130
Mar 11, 2026Covidien LLC
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 108845
Open, Classified
MWIK160718
Jan 22, 2026Edan Diagnostics
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intend
Open, Classified
MWIK202892
K233038
Jul 2, 2025CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Cardiology Hemodynamics Software
Open, Classified
MWIK230881
Jul 2, 2025CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Cardiology Hemo Software
Open, Classified
MWIK131497
Apr 29, 2025Spectrum Medical Ltd.
Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only dev
Open, Classified
MWINone listed
Apr 29, 2025Spectrum Medical Ltd.
Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is inten
Open, Classified
MWINone listed
Apr 15, 2025Baxter Healthcare Corporation
Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.
Open, Classified
MWIK142356
Apr 14, 2025Baxter Healthcare Corporation
Welch Allyn CONNEX Accessory Power Management Stand:
Open, Classified
MWIK241411
Jan 16, 2025A L I Technologies Ltd
Change Healthcare Cardiology Hemodynamics software
Open, Classified
MWIK230881
Jan 16, 2025A L I Technologies Ltd
Change Healthcare Cardiology Hemo software
Open, Classified
MWIK131497
Jan 16, 2025A L I Technologies Ltd
McKesson Cardiology Hemo software
Open, Classified
MWIK131497
Jan 15, 2025GE Medical Systems, LLC
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facil
Open, Classified
MWIK234130
Oct 17, 2024CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
Open, Classified
MWIK131497
May 30, 2024PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
Open, Classified
MWIK181311
Sep 12, 2023Baxter Healthcare Corporation
Welch Allyn Connex Spot Monitor
Open, Classified
MWIK142356
Oct 4, 2022Philips North America Llc
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Open, Classified
MWIK212227
Feb 22, 2022Philips North America Llc
Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodynamic data in the Philips Interventional Hemodynamic
Terminated
MWIK181311
Mar 29, 2021Philips North America Llc
Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service n
Open, Classified
MWIK101571
Jun 18, 2020Philips North America, LLC
Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for
Terminated
MWIK090785
K131382
Jun 18, 2020Philips North America, LLC
Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs
Terminated
MWIK090785
K131382
Jun 18, 2020Philips North America, LLC
Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor
Terminated
MWIK090785
Apr 13, 2020Philips North America, LLC
Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-d
Terminated
MWIK080038
Apr 13, 2020Philips North America, LLC
Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respi
Terminated
MWIK090785
Feb 20, 2020Philips North America, LLC
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product Usage: The Expression Model MR400 MRI Patient Monitor
Terminated
MWIK152330
Oct 1, 2019Mindray DS USA, Inc. dba Mindray North America
Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic paramete
Terminated
MWIK132037
Oct 1, 2019Mindray DS USA, Inc. dba Mindray North America
Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, includin
Terminated
MWIK170712
Oct 1, 2019Mindray DS USA, Inc. dba Mindray North America
Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, inc
Terminated
MWIK182821
Oct 1, 2019Mindray DS USA, Inc. dba Mindray North America
Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic param
Terminated
MWIK132037
May 31, 2019Infinium Medical, Inc
CLEO Patient Monitor /Tranquility VS Patient Monitor
Open, Classified
MWIK142244
Aug 3, 2018Invivo Corporation
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Terminated
MWIK101571
Mar 14, 2018Invivo Corporation
PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used t
Terminated
MWINone listed
Nov 20, 2017Invivo Corporation
Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant
Open, Classified
MWIK101571
Aug 18, 2017Invivo Corporation
Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
Terminated
MWIK101571
Aug 11, 2017Invivo Corporation
Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant
Terminated
MWIK101571
Aug 19, 2016INNOKAS MEDICAL OY
CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
Terminated
MWIK133810
Nov 11, 2015Innokas Medical Oy
CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
Terminated
MWIK133810
Oct 19, 2015Invivo Corporation
The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.
Terminated
MWIK101571
Jul 27, 2015Philips Electronics North America Corporation
Invivo Expression MRI Patient Monitoring System.
Terminated
MWIK124061
Jan 28, 2015INNOKAS MEDICAL OY
VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, a
Terminated
MWIK133810
Jan 13, 2015Invivo Corporation
Philips Expression MR200 MRI Patient Monitoring System.
Terminated
MWIK131382
Oct 20, 2014Mckesson Information Solutions LLC
McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessm
Terminated
MWIK131497

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