FDA Product Code
FDA Product Code MWI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2300
510(k) Clearances — 308 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260438 | Vital Signs Monitor (CLEO2) | Infinium Medical, Inc. | 2026-08-14 | Traditional | PDF ↗ |
| K253417 | Masimo Root Monitoring System | Masimo Corporation | 2026-08-12 | Traditional | PDF ↗ |
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Midmark Corporation | 2026-06-12 | Traditional | PDF ↗ |
| K253436 | c-med0 alpha | Cosinuss GmbH | 2026-04-30 | Traditional | PDF ↗ |
| K250135 | WAVE Clinical Platform (2.0.000) | Baxter Healthcare Corp/ Excel Medical | 2026-01-16 | Traditional | PDF ↗ |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | Fysicon BV | 2025-08-27 | Traditional | PDF ↗ |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2025-06-06 | Traditional | PDF ↗ |
| K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | 2025-02-14 | Traditional | PDF ↗ |
| K243146 | iCare APP | Ihealth Labs, Inc. | 2025-02-03 | Traditional | PDF ↗ |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Welch Allyn, Inc. | 2024-12-20 | Traditional | PDF ↗ |
| K243216 | Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) | Analog Devices | 2024-12-10 | Traditional | PDF ↗ |
| K233446 | AMC Health CareConsole | Amc Health | 2024-09-27 | Traditional | PDF ↗ |
| K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024-09-24 | Traditional | PDF ↗ |
| K233354 | WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. | 2024-06-26 | Traditional | PDF ↗ |
| K232111 | NeoBeat, NeoBeat Mini | Laerdal Medical AS | 2024-06-25 | Traditional | PDF ↗ |
| K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | 2024-04-25 | Traditional | PDF ↗ |
| K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC | 2024-04-01 | Traditional | PDF ↗ |
| K234130 | Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O | Ge Medical Systems Information Technologies, Inc. | 2024-03-20 | Traditional | PDF ↗ |
| K233038 | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s | Edan Instruments, Inc. | 2024-03-08 | Traditional | PDF ↗ |
| K231086 | CPM System | Analog Devices, Inc. | 2023-12-22 | Traditional | PDF ↗ |
| K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023-10-30 | Traditional | PDF ↗ |
| K230881 | Change Healthcare Cardiology Hemodynamics | Change Healthcare Israel , Ltd. | 2023-09-11 | Traditional | PDF ↗ |
| K230626 | Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Alarming Unit (Portrait CAU01); Portrait Mobile Patient Monitor (Portrait HUB01), Portrait Sensor Battery (Portrait SBT01), Portrait Bedside Charger (Portrait BCH01); Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait SpO2 Attachment Accessory Band (Portrait AAB01), Portrait | Ge Medical Systems Information Technologies, Inc. | 2023-08-11 | Traditional | PDF ↗ |
| K220117 | ARC Intensive Care Information System (ARC System) | Ordinatrum Solutions | 2023-06-06 | Traditional | PDF ↗ |
| K230214 | Huma RPM (RPM) | Medopad, Inc. | 2023-06-02 | Traditional | PDF ↗ |
| K222330 | The Heart Seat | Casana Care, Inc. | 2023-04-24 | Traditional | PDF ↗ |
| K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories | Masimo Corporation | 2023-03-06 | Traditional | PDF ↗ |
| K221267 | VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2022-12-15 | Traditional | PDF ↗ |
| K221113 | Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-12-02 | Traditional | PDF ↗ |
| K212473 | Welch Allyn Connex Central Station | Welch Allyn, Inc. | 2022-10-28 | Traditional | PDF ↗ |
| K212975 | MedWand | Medwand Solutions, Inc. | 2022-07-22 | Traditional | PDF ↗ |
| K213335 | Capsule Surveillance System | Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. | 2022-01-14 | Traditional | PDF ↗ |
| K211754 | Vital Signs Monitor | Beijing Choice Electronic Technology Co., Ltd. | 2021-11-15 | Traditional | PDF ↗ |
| K210204 | Capsule Vitals Plus Patient Monitoring System | Capsule Technologie Sas | 2021-10-19 | Traditional | PDF ↗ |
| K211475 | Vital Signs Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-10-05 | Traditional | PDF ↗ |
| K212227 | Philips MR Patient Care Portal | Invivo Corporation | 2021-09-30 | Traditional | PDF ↗ |
| K210086 | Vitals360 Multi-Vitals Mobile Monitor | Vocare, Inc. | 2021-05-20 | Traditional | PDF ↗ |
| K202375 | ZOLL Propaq M | ZOLL Medical Corporation | 2021-03-09 | Traditional | PDF ↗ |
| K200160 | 740 SafeSAT | Zoe Medical, Inc. | 2021-02-15 | Traditional | PDF ↗ |
| K201635 | MouthLab Vital Signs Monitoring System | Multisensor Diagnostics (Dba Aidar Health) | 2021-02-06 | Traditional | PDF ↗ |
| K202892 | Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s | Edan Instruments, Inc. | 2021-01-28 | Traditional | PDF ↗ |
| K202306 | T3 Platform software | Etiometry, Inc. | 2020-11-25 | Traditional | PDF ↗ |
| K193626 | Masimo Rad-97 Pulse CO-Oximeter and Accessories | Masimo Corporation | 2020-08-10 | Traditional | PDF ↗ |
| K200856 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie Sas | 2020-07-10 | Traditional | PDF ↗ |
| K200141 | Oxi-W System | Ld Technology, LLC | 2020-04-27 | Special | PDF ↗ |
| K191882 | Masimo Centroid System | Masimo Corporation | 2020-04-22 | Traditional | PDF ↗ |
| K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories | Masimo Corporation | 2020-02-27 | Traditional | PDF ↗ |
| K191989 | WVSM (Wireless Vital Signs Monitor) RWC + miniCap | Athena Gtx | 2020-01-29 | Traditional | PDF ↗ |
| K192004 | Eko Analysis Software | Eko Devices, Inc. | 2020-01-15 | Traditional | PDF ↗ |
| K191059 | Masimo Rad-97 and Accessories | Masimo Corporation | 2019-12-27 | Traditional | PDF ↗ |
| K190273 | T3 Platform software | Etiometry, Inc. | 2019-12-08 | Traditional | PDF ↗ |
| K183687 | LifeWindow LW8 Lite | Digicare Biomedical Technology, Inc. | 2019-09-25 | Traditional | PDF ↗ |
| K183370 | PeraMobile and PeraWatch | Perahealth, Inc. | 2019-09-11 | Traditional | PDF ↗ |
| K182401 | B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter | Amzetta Technologies Private Limited | 2019-08-28 | Traditional | PDF ↗ |
| K190090 | DynoSense Vital Sign Measuring System | Dynosense Corp. | 2019-08-02 | Traditional | PDF ↗ |
| K190468 | Nihon Kohden SVM-7200 Series Vital Signs Monitor | Nihon Kohden Corporation | 2019-05-28 | Traditional | PDF ↗ |
| K183697 | Masimo Rad-97 and Accessories | Masimo Corporation | 2019-05-15 | Traditional | PDF ↗ |
| K183634 | Stasis Monitoring System | Stasis Labs, Inc. | 2019-04-17 | Traditional | PDF ↗ |
| K183638 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie | 2019-04-17 | Special | PDF ↗ |
| K181541 | Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK | Andon Health Co, Ltd. | 2019-04-16 | Traditional | PDF ↗ |
| K181919 | Patient Monitor | Guangdong Biolight Meditech Co., Ltd. | 2019-04-05 | Traditional | PDF ↗ |
| K180903 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2019-03-29 | Traditional | PDF ↗ |
| K182821 | Accutorr 7/VS-900/VS-900c Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-03-27 | Special | PDF ↗ |
| K172965 | Handheld VitalSigns Monitoring System | Visiomed Technology Co.,Ltd | 2018-12-17 | Traditional | PDF ↗ |
| K182900 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2018-12-14 | Traditional | PDF ↗ |
| K183116 | Unity Network ID | GE Healthcare | 2018-12-06 | Special | PDF ↗ |
| K182226 | AirStrip RPM InvisionHeart Adapter | Airstrip Technologies, Inc. | 2018-09-11 | Traditional | PDF ↗ |
| K181311 | Philips Hemodynamic Application R1.0 | Philips Medical Systems Nederlands B.V. | 2018-09-07 | Abbreviated | PDF ↗ |
| K180734 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie | 2018-08-08 | Traditional | PDF ↗ |
| K172221 | VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 | Taidoc Technology Corporation | 2018-06-06 | Traditional | PDF ↗ |
| K172147 | STAR 65 | Skanray Technologies Pvt, Ltd. | 2018-05-25 | Traditional | PDF ↗ |
| K172959 | PeraServer and PeraTrend | Perahealth, Inc. | 2018-05-01 | Traditional | PDF ↗ |
| K171361 | BETTERCARE PLATFORM - ADVANCED WEB CLIENT | Better Care S.L. | 2018-02-05 | Traditional | PDF ↗ |
| K171056 | WAVE Clinical Platform | Excel Medical Electronics, LLC | 2018-01-04 | Traditional | PDF ↗ |
| K171121 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2017-11-17 | Traditional | PDF ↗ |
| K172200 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2017-10-25 | Traditional | PDF ↗ |
| K171751 | SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module | Capsule Technologie Sas | 2017-10-24 | Traditional | PDF ↗ |
| K170538 | RVS-100 Vital Signs Monitor | Rudolf Riester GmbH | 2017-10-17 | Traditional | PDF ↗ |
| K170168 | Masimo Rad-97 and Accessories | Masimo Corporation | 2017-09-14 | Traditional | PDF ↗ |
| K170047 | All-in-One Health Monitor, PC-303 | Shenzhen Creative Industry Co., Ltd. | 2017-09-09 | Traditional | PDF ↗ |
| K170032 | QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP | Fysicon BV | 2017-09-08 | Traditional | PDF ↗ |
| K170712 | Accutorr 7/VS-900 Vital Signs Monitor | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017-08-02 | Traditional | PDF ↗ |
| K170798 | Dictum Health | Dictum Health, Inc. | 2017-07-14 | Abbreviated | PDF ↗ |
| K160899 | CoVa Monitoring System 2 | Tosense, Inc. | 2017-06-22 | Traditional | PDF ↗ |
| K163065 | T3 Software | Etiometry, Inc. | 2017-05-26 | Traditional | PDF ↗ |
| K170199 | Unity Network ID | GE Healthcare | 2017-05-12 | Special | PDF ↗ |
| K162234 | Truscope Ultra Patient Monitor | Guangdong Biolight Meditech Co., Ltd. | 2017-01-04 | Special | PDF ↗ |
| K161909 | IQvitals Zone | Midmark Corporation | 2016-11-17 | Traditional | PDF ↗ |
| K160718 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | 2016-11-14 | Traditional | PDF ↗ |
| K151839 | AMC Health VitalCaregiving System | Amc Health | 2016-09-09 | Traditional | PDF ↗ |
| K160956 | LD-Oxi system | Ld Technology, LLC | 2016-07-06 | Special | PDF ↗ |
| K153739 | MRI Patient Monitor TeslaDUO | Mipm Mammendorfer Institut Fur Physik Und Medizin | 2016-06-28 | Traditional | PDF ↗ |
| K153225 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2016-06-21 | Traditional | PDF ↗ |
| K153079 | Axeo 3 Patient Monitor | Axeo Medical Technologies, LLC | 2016-03-17 | Traditional | PDF ↗ |
| K153335 | AlertWatch: OR | Alertwatch, LLC | 2016-03-15 | Traditional | PDF ↗ |
| K153135 | VITAL SIGNS MONITOR | Guangdong Biolight Meditech Co., Ltd. | 2016-02-25 | Special | PDF ↗ |
| K151512 | Star 60 | Skanray Technologies Private Limited | 2016-02-14 | Traditional | PDF ↗ |
| K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016-02-12 | Traditional | PDF ↗ |
| K152645 | Dictum Health | Dictum Health, Inc. | 2016-02-09 | Abbreviated | PDF ↗ |
| K152330 | Expression MR400 MRI Patient Monitoring System | Invivo Corporation | 2015-12-23 | Special | PDF ↗ |
Product code MWI · Class II · Cardiovascular. Data: openFDA.