MWI · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cardiovascular · 21 CFR 870.2300 · Class 2
Overview
| Product Code | MWI |
|---|---|
| Device Name | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 304)
Showing 20 most recent of 304 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250135 | WAVE Clinical Platform (2.0.000) | Baxter Healthcare Corp/ Excel Medical | Jan 16, 2026 | SESE |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | Fysicon BV | Aug 27, 2025 | SESE |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | Jun 6, 2025 | SESE |
| K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | Feb 14, 2025 | SESE |
| K243146 | iCare APP | Ihealth Labs, Inc. | Feb 3, 2025 | SESE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Welch Allyn, Inc. | Dec 20, 2024 | SESE |
| K243216 | Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) | Analog Devices | Dec 10, 2024 | SESE |
| K233446 | AMC Health CareConsole | Amc Health | Sep 27, 2024 | SESE |
| K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | Sep 24, 2024 | SESE |
| K233354 | WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. | Jun 26, 2024 | SESE |
| K232111 | NeoBeat, NeoBeat Mini | Laerdal Medical AS | Jun 25, 2024 | SESE |
| K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | Apr 25, 2024 | SESE |
| K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC | Apr 1, 2024 | SESE |
| 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. | Mar 20, 2024 | SESE |
| K233038 | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s | Edan Instruments, Inc. | Mar 8, 2024 | SESE |
| K231086 | CPM System | Analog Devices, Inc. | Dec 22, 2023 | SESE |
| K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | Oct 30, 2023 | SESE |
| K230881 | Change Healthcare Cardiology Hemodynamics | Change Healthcare Israel , Ltd. | Sep 11, 2023 | SESE |
| 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. | Aug 11, 2023 | SESE |
| K220117 | ARC Intensive Care Information System (ARC System) | Ordinatrum Solutions | Jun 6, 2023 | SESE |
Top Applicants
- Larsen & Toubro Limited — 15 clearances
- Masimo Corporation — 12 clearances
- Welch Allyn, Inc. — 12 clearances
- Agilent Technologies, Inc. — 11 clearances
- Airstrip Technologies, LP — 8 clearances
