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)
Top companies in MWI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | Midmark 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 |
MWI | K161909 |
| Sep 18, 2026 | Midmark 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 |
MWI | K161909 |
| Sep 18, 2026 | Midmark 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 |
MWI | K161909 |
| Sep 18, 2026 | Midmark 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 |
MWI | K161909 |
| Aug 27, 2026 | GE Medical Systems Information Technologies Inc FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225 Open, Classified |
MWI | None listed |
| Aug 27, 2026 | GE Medical Systems Information Technologies Inc PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 Open, Classified |
MWI | K230626 |
| Aug 27, 2026 | GE Medical Systems Information Technologies Inc PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 Open, Classified |
MWI | K234130 |
| Aug 27, 2026 | GE Medical Systems Information Technologies Inc PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 Open, Classified |
MWI | K234130 |
| Aug 4, 2026 | GE Medical Systems Information Technologies Inc GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592 Open, Classified |
MWI | K234130 |
| Mar 11, 2026 | Covidien 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 |
MWI | K160718 |
| Jan 22, 2026 | Edan 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 |
MWI | K202892 K233038 |
| Jul 2, 2025 | CHANGE HEALTHCARE CANADA COMPANY Change Healthcare Cardiology Hemodynamics Software Open, Classified |
MWI | K230881 |
| Jul 2, 2025 | CHANGE HEALTHCARE CANADA COMPANY Change Healthcare Cardiology Hemo Software Open, Classified |
MWI | K131497 |
| Apr 29, 2025 | Spectrum 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 |
MWI | None listed |
| Apr 29, 2025 | Spectrum 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 |
MWI | None listed |
| Apr 15, 2025 | Baxter 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 |
MWI | K142356 |
| Apr 14, 2025 | Baxter Healthcare Corporation Welch Allyn CONNEX Accessory Power Management Stand: Open, Classified |
MWI | K241411 |
| Jan 16, 2025 | A L I Technologies Ltd Change Healthcare Cardiology Hemodynamics software Open, Classified |
MWI | K230881 |
| Jan 16, 2025 | A L I Technologies Ltd Change Healthcare Cardiology Hemo software Open, Classified |
MWI | K131497 |
| Jan 16, 2025 | A L I Technologies Ltd McKesson Cardiology Hemo software Open, Classified |
MWI | K131497 |
| Jan 15, 2025 | GE 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 |
MWI | K234130 |
| Oct 17, 2024 | CHANGE 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 |
MWI | K131497 |
| May 30, 2024 | PHILIPS 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 |
MWI | K181311 |
| Sep 12, 2023 | Baxter Healthcare Corporation Welch Allyn Connex Spot Monitor Open, Classified |
MWI | K142356 |
| Oct 4, 2022 | Philips North America Llc MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561
This is a component of product number 866162. Open, Classified |
MWI | K212227 |
| Feb 22, 2022 | Philips 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 |
MWI | K181311 |
| Mar 29, 2021 | Philips 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 |
MWI | K101571 |
| Jun 18, 2020 | Philips 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 |
MWI | K090785 K131382 |
| Jun 18, 2020 | Philips 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 |
MWI | K090785 K131382 |
| Jun 18, 2020 | Philips 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 |
MWI | K090785 |
| Apr 13, 2020 | Philips 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 |
MWI | K080038 |
| Apr 13, 2020 | Philips 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 |
MWI | K090785 |
| Feb 20, 2020 | Philips 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 |
MWI | K152330 |
| Oct 1, 2019 | Mindray 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 |
MWI | K132037 |
| Oct 1, 2019 | Mindray 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 |
MWI | K170712 |
| Oct 1, 2019 | Mindray 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 |
MWI | K182821 |
| Oct 1, 2019 | Mindray 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 |
MWI | K132037 |
| May 31, 2019 | Infinium Medical, Inc CLEO Patient Monitor /Tranquility VS Patient Monitor Open, Classified |
MWI | K142244 |
| Aug 3, 2018 | Invivo Corporation Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388 Terminated |
MWI | K101571 |
| Mar 14, 2018 | Invivo 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 |
MWI | None listed |
| Nov 20, 2017 | Invivo 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 |
MWI | K101571 |
| Aug 18, 2017 | Invivo Corporation Xper Flex Cardio Physiomonitoring system.
Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such. Terminated |
MWI | K101571 |
| Aug 11, 2017 | Invivo 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 |
MWI | K101571 |
| Aug 19, 2016 | INNOKAS MEDICAL OY CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care. Terminated |
MWI | K133810 |
| Nov 11, 2015 | Innokas Medical Oy CARESCAPE VC150 Vital Signs Monitor
Monitor vital signs in humans Terminated |
MWI | K133810 |
| Oct 19, 2015 | Invivo 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 |
MWI | K101571 |
| Jul 27, 2015 | Philips Electronics North America Corporation Invivo Expression MRI Patient Monitoring System. Terminated |
MWI | K124061 |
| Jan 28, 2015 | INNOKAS 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 |
MWI | K133810 |
| Jan 13, 2015 | Invivo Corporation Philips Expression MR200 MRI Patient Monitoring System. Terminated |
MWI | K131382 |
| Oct 20, 2014 | Mckesson 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 |
MWI | K131497 |
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