| Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) (K253196) | Midmark Corporation | 2026-06-12 |
| c-med0 alpha (K253436) | Cosinuss GmbH | 2026-04-30 |
| WAVE Clinical Platform (2.0.000) (K250135) | Baxter Healthcare Corp/ Excel Medical | 2026-01-16 |
| QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) (K241766) | Fysicon BV | 2025-08-27 |
| Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (K242737) | Empatica S.r.l. | 2025-06-06 |
| WARD-CSS (v1.2.x) (K241958) | Ward 24/7 Aps | 2025-02-14 |
| iCare APP (K243146) | Ihealth Labs, Inc. | 2025-02-03 |
| Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (K241411) | Welch Allyn, Inc. | 2024-12-20 |
| Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) (K243216) | Analog Devices | 2024-12-10 |
| AMC Health CareConsole (K233446) | Amc Health | 2024-09-27 |
| Happy Ring Health Monitoring System (K240236) | Happy Health, Inc. | 2024-09-24 |
| WVSM Pro (Series) (500-0030-XX) (K233354) | Athena Gtx, Inc. | 2024-06-26 |
| NeoBeat, NeoBeat Mini (K232111) | Laerdal Medical AS | 2024-06-25 |
| Portrait VSM (K233810) | Ge Medical Systems Information Technologies, Inc. | 2024-04-25 |
| Talis EMR with Talis +ACG (Talis EMR with +ACG) (K233133) | Talis Clinical, LLC | 2024-04-01 |
| 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 (K234130) | Ge Medical Systems Information Technologies, Inc. | 2024-03-20 |
| Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s (K233038) | Edan Instruments, Inc. | 2024-03-08 |
| CPM System (K231086) | Analog Devices, Inc. | 2023-12-22 |
| Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (K230457) | Empatica S.r.l. | 2023-10-30 |
| Change Healthcare Cardiology Hemodynamics™ (K230881) | Change Healthcare Israel , Ltd. | 2023-09-11 |
| 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™ (K230626) | Ge Medical Systems Information Technologies, Inc. | 2023-08-11 |
| ARC Intensive Care Information System (ARC System) (K220117) | Ordinatrum Solutions | 2023-06-06 |
| Huma RPM (RPM) (K230214) | Medopad, Inc. | 2023-06-02 |
| The Heart Seat (K222330) | Casana Care, Inc. | 2023-04-24 |
| Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories (K212161) | Masimo Corporation | 2023-03-06 |
| VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor (K221267) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2022-12-15 |
| Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor (K221113) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-12-02 |
| Welch Allyn Connex Central Station (K212473) | Welch Allyn, Inc. | 2022-10-28 |
| MedWand (K212975) | Medwand Solutions, Inc. | 2022-07-22 |
| Capsule Surveillance System (K213335) | Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. | 2022-01-14 |
| Vital Signs Monitor (K211754) | Beijing Choice Electronic Technology Co., Ltd. | 2021-11-15 |
| Capsule Vitals Plus Patient Monitoring System (K210204) | Capsule Technologie Sas | 2021-10-19 |
| Vital Signs Monitors (K211475) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-10-05 |
| Philips MR Patient Care Portal (K212227) | Invivo Corporation | 2021-09-30 |
| Vitals360 Multi-Vitals Mobile Monitor (K210086) | Vocare, Inc. | 2021-05-20 |
| ZOLL Propaq M (K202375) | ZOLL Medical Corporation | 2021-03-09 |
| 740 SafeSAT (K200160) | Zoe Medical, Inc. | 2021-02-15 |
| MouthLab Vital Signs Monitoring System (K201635) | Multisensor Diagnostics (Dba Aidar Health) | 2021-02-06 |
| Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s (K202892) | Edan Instruments, Inc. | 2021-01-28 |
| T3 Platform software (K202306) | Etiometry, Inc. | 2020-11-25 |
| Masimo Rad-97 Pulse CO-Oximeter and Accessories (K193626) | Masimo Corporation | 2020-08-10 |
| SmartLinx Vitals Plus Patient Monitoring System (K200856) | Capsule Technologie Sas | 2020-07-10 |
| Oxi-W System (K200141) | Ld Technology, LLC | 2020-04-27 |
| Masimo Centroid System (K191882) | Masimo Corporation | 2020-04-22 |
| Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories (K193242) | Masimo Corporation | 2020-02-27 |
| WVSM (Wireless Vital Signs Monitor) RWC + miniCap (K191989) | Athena Gtx | 2020-01-29 |
| Eko Analysis Software (K192004) | Eko Devices, Inc. | 2020-01-15 |
| Masimo Rad-97 and Accessories (K191059) | Masimo Corporation | 2019-12-27 |
| T3 Platform software (K190273) | Etiometry, Inc. | 2019-12-08 |
| LifeWindow LW8 Lite (K183687) | Digicare Biomedical Technology, Inc. | 2019-09-25 |
| PeraMobile and PeraWatch (K183370) | Perahealth, Inc. | 2019-09-11 |
| 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 (K182401) | Amzetta Technologies Private Limited | 2019-08-28 |
| DynoSense Vital Sign Measuring System (K190090) | Dynosense Corp. | 2019-08-02 |
| Nihon Kohden SVM-7200 Series Vital Signs Monitor (K190468) | Nihon Kohden Corporation | 2019-05-28 |
| Masimo Rad-97 and Accessories (K183697) | Masimo Corporation | 2019-05-15 |
| SmartLinx Vitals Plus Patient Monitoring System (K183638) | Capsule Technologie | 2019-04-17 |
| Stasis Monitoring System (K183634) | Stasis Labs, Inc. | 2019-04-17 |
| Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK (K181541) | Andon Health Co, Ltd. | 2019-04-16 |
| Patient Monitor (K181919) | Guangdong Biolight Meditech Co., Ltd. | 2019-04-05 |
| 3880 MRI Patient Monitoring System (K180903) | Iradimed Corporation | 2019-03-29 |
| Accutorr 7/VS-900/VS-900c Vital Signs Monitor (K182821) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-03-27 |
| Handheld VitalSigns Monitoring System (K172965) | Visiomed Technology Co.,Ltd | 2018-12-17 |
| 3880 MRI Patient Monitoring System (K182900) | Iradimed Corporation | 2018-12-14 |
| Unity Network ID (K183116) | GE Healthcare | 2018-12-06 |
| AirStrip RPM InvisionHeart Adapter (K182226) | Airstrip Technologies, Inc. | 2018-09-11 |
| Philips Hemodynamic Application R1.0 (K181311) | Philips Medical Systems Nederlands B.V. | 2018-09-07 |
| SmartLinx Vitals Plus Patient Monitoring System (K180734) | Capsule Technologie | 2018-08-08 |
| VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 (K172221) | Taidoc Technology Corporation | 2018-06-06 |
| STAR 65 (K172147) | Skanray Technologies Pvt, Ltd. | 2018-05-25 |
| PeraServer and PeraTrend (K172959) | Perahealth, Inc. | 2018-05-01 |
| BETTERCARE PLATFORM - ADVANCED WEB CLIENT (K171361) | Better Care S.L. | 2018-02-05 |
| WAVE Clinical Platform (K171056) | Excel Medical Electronics, LLC | 2018-01-04 |
| Masimo Root Monitoring System and Accessories (K171121) | Masimo Corporation | 2017-11-17 |
| 3880 MRI Patient Monitoring System (K172200) | Iradimed Corporation | 2017-10-25 |
| 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 (K171751) | Capsule Technologie Sas | 2017-10-24 |
| RVS-100 Vital Signs Monitor (K170538) | Rudolf Riester GmbH | 2017-10-17 |
| Masimo Rad-97 and Accessories (K170168) | Masimo Corporation | 2017-09-14 |
| All-in-One Health Monitor, PC-303 (K170047) | Shenzhen Creative Industry Co., Ltd. | 2017-09-09 |
| QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP (K170032) | Fysicon BV | 2017-09-08 |
| Accutorr 7/VS-900 Vital Signs Monitor (K170712) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017-08-02 |
| Dictum Health (K170798) | Dictum Health, Inc. | 2017-07-14 |
| CoVa Monitoring System 2 (K160899) | Tosense, Inc. | 2017-06-22 |
| T3 Software (K163065) | Etiometry, Inc. | 2017-05-26 |
| Unity Network ID (K170199) | GE Healthcare | 2017-05-12 |
| Truscope Ultra Patient Monitor (K162234) | Guangdong Biolight Meditech Co., Ltd. | 2017-01-04 |
| IQvitals Zone (K161909) | Midmark Corporation | 2016-11-17 |
| Vital Sync Informatics Manager & Virtual Patient Monitoring Platform (K160718) | Covidien | 2016-11-14 |
| AMC Health VitalCaregiving System (K151839) | Amc Health | 2016-09-09 |
| LD-Oxi system (K160956) | Ld Technology, LLC | 2016-07-06 |
| MRI Patient Monitor TeslaDUO (K153739) | Mipm Mammendorfer Institut Fur Physik Und Medizin | 2016-06-28 |
| Masimo Root Monitoring System and Accessories (K153225) | Masimo Corporation | 2016-06-21 |
| Axeo 3 Patient Monitor (K153079) | Axeo Medical Technologies, LLC | 2016-03-17 |
| AlertWatch: OR (K153335) | Alertwatch, LLC | 2016-03-15 |
| VITAL SIGNS MONITOR (K153135) | Guangdong Biolight Meditech Co., Ltd. | 2016-02-25 |
| Star 60 (K151512) | Skanray Technologies Private Limited | 2016-02-14 |
| Masimo Root Vital Signs Monitoring System and Accessories (K151644) | Masimo Corporation | 2016-02-12 |
| Dictum Health (K152645) | Dictum Health, Inc. | 2016-02-09 |
| Expression MR400 MRI Patient Monitoring System (K152330) | Invivo Corporation | 2015-12-23 |
| ViSi Mobile Monitoring System (K152341) | Sotera Wireless, Inc. | 2015-12-14 |
| Checkme Pro Health Monitor (K150869) | Viatom Technology Co., Ltd. | 2015-12-10 |