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

Company510(k)sRecalls
Invivo Corp.817
Ge Medical Systems Information Technologies126
Larsen & Toubro Limited150
Masimo Corporation130
Welch Allyn, Inc.120
Agilent Technologies, Inc.110
Philips Medical Systems100
Airstrip Technologies, Inc.90
Capsule Technologie90
Philips North America Llc09
Decided510(k)Device and applicantCode
Oct 16, 2026K260801Sensinel Cardiopulmonary Management (CPM) System
Analog Devices
MWI
Aug 14, 2026K260438Vital Signs Monitor (CLEO2)
Infinium Medical, Inc.
MWI
Aug 12, 2026K253417Masimo Root Monitoring System
Masimo Corporation
MWI
Jun 12, 2026K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)
Midmark Corporation
MWI
Apr 30, 2026K253436c-med0 alpha
Cosinuss GmbH, DE
MWI
Jan 16, 2026K250135WAVE Clinical Platform (2.0.000)
Baxter Healthcare Corp/ Excel Medical
MWI
Aug 27, 2025K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
Fysicon BV, NL
MWI
Jun 6, 2025K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
Empatica S.r.l., IT
MWI
Feb 14, 2025K241958WARD-CSS (v1.2.x)
Ward 24/7 Aps, DK
MWI
Feb 3, 2025K243146iCare APP
Ihealth Labs, Inc.
MWI
Dec 20, 2024K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)
Welch Allyn, Inc.
MWI
Dec 10, 2024K243216Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)
Analog Devices
MWI
Sep 27, 2024K233446AMC Health CareConsole
Amc Health
MWI
Sep 24, 2024K240236Happy Ring Health Monitoring System
Happy Health, Inc.
MWI
Jun 26, 2024K233354WVSM Pro (Series) (500-0030-XX)
Athena Gtx, Inc.
MWI
Jun 25, 2024K232111NeoBeat, NeoBeat Mini
Laerdal Medical AS, NO
MWI
Apr 25, 2024K233810Portrait VSM
Ge Medical Systems Information Technologies, Inc.
MWI
Apr 1, 2024K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)
Talis Clinical, LLC
MWI
Mar 20, 2024K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™
Ge Medical Systems Information Technologies, Inc.
MWI
Mar 8, 2024K233038Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
Edan Instruments, Inc., CN
MWI
Dec 22, 2023K231086CPM System
Analog Devices, Inc.
MWI
Oct 30, 2023K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
Empatica S.r.l., IT
MWI
Sep 11, 2023K230881Change Healthcare Cardiology Hemodynamics™
Change Healthcare Israel , Ltd., IL
MWI
Aug 11, 2023K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Al
Ge Medical Systems Information Technologies, Inc.
MWI
Jun 6, 2023K220117ARC Intensive Care Information System (ARC System)
Ordinatrum Solutions
MWI
Jun 2, 2023K230214Huma RPM (RPM)
Medopad, Inc.
MWI
Apr 24, 2023K222330The Heart Seat
Casana Care, Inc.
MWI
Mar 6, 2023K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories
Masimo Corporation
MWI
Dec 15, 2022K221267VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd., CN
MWI
Dec 2, 2022K221113Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MWI
Oct 28, 2022K212473Welch Allyn Connex Central Station
Welch Allyn, Inc.
MWI
Jul 22, 2022K212975MedWand
Medwand Solutions, Inc.
MWI
Jan 14, 2022K213335Capsule Surveillance System
Capsule Surveillance Technologies, Sas /Capsule Tech, Inc.
MWI
Nov 15, 2021K211754Vital Signs Monitor
Beijing Choice Electronic Technology Co., Ltd., CN
MWI
Oct 19, 2021K210204Capsule Vitals Plus Patient Monitoring System
Capsule Technologie Sas, FR
MWI
Oct 5, 2021K211475Vital Signs Monitors
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MWI
Sep 30, 2021K212227Philips MR Patient Care Portal
Invivo Corporation
MWI
May 20, 2021K210086Vitals360 Multi-Vitals Mobile Monitor
Vocare, Inc.
MWI
Mar 9, 2021K202375ZOLL Propaq M
ZOLL Medical Corporation
MWI
Feb 15, 2021K200160740 SafeSAT
Zoe Medical, Inc.
MWI
Feb 6, 2021K201635MouthLab Vital Signs Monitoring System
Multisensor Diagnostics (Dba Aidar Health)
MWI
Jan 28, 2021K202892Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s
Edan Instruments, Inc., CN
MWI
Nov 25, 2020K202306T3 Platform software
Etiometry, Inc.
MWI
Aug 10, 2020K193626Masimo Rad-97 Pulse CO-Oximeter and Accessories
Masimo Corporation
MWI
Jul 10, 2020K200856SmartLinx Vitals Plus Patient Monitoring System
Capsule Technologie Sas
MWI
Apr 27, 2020K200141Oxi-W System
Ld Technology, LLC
MWI
Apr 22, 2020K191882Masimo Centroid System
Masimo Corporation
MWI
Feb 27, 2020K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pul
Masimo Corporation
MWI
Jan 29, 2020K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCap
Athena Gtx
MWI
Jan 15, 2020K192004Eko Analysis Software
Eko Devices, Inc.
MWI

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