MWI
- Product code
- MWI
- Device name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.2300
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 22
- Summaries archived here
- 17 (direct download)
- 510(k) clearances (all years, FDA)
- 308 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (22)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260438 | 2026-08-14 | Infinium Medical, Inc. | Vital Signs Monitor (CLEO2) | — |
| K253417 | 2026-08-12 | Masimo Corporation | Masimo Root Monitoring System | FDA |
| K253196 | 2026-06-12 | Midmark Corporation | Midmark 800 Digital Vital Signs Device (1-300-0100, | |
| K253436 | 2026-04-30 | Cosinuss GmbH | c-med0 alpha | |
| K250135 | 2026-01-16 | Baxter Healthcare Corp/ Excel Medical | WAVE Clinical Platform (2.0.000) | |
| K241766 | 2025-08-27 | Fysicon BV | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | |
| K242737 | 2025-06-06 | Empatica S.r.l. | Empatica Health Monitoring Platform; EmbracePlus; Em | |
| K241958 | 2025-02-14 | Ward 24/7 Aps | WARD-CSS (v1.2.x) | |
| K243146 | 2025-02-03 | Ihealth Labs, Inc. | iCare APP | |
| K241411 | 2024-12-20 | Welch Allyn, Inc. | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs | |
| K243216 | 2024-12-10 | Analog Devices | Sensinel Cardiopulmonary Management (CPM) System (AD | — |
| K233446 | 2024-09-27 | Amc Health | AMC Health CareConsole | |
| K240236 | 2024-09-24 | Happy Health, Inc. | Happy Ring Health Monitoring System | |
| K233354 | 2024-06-26 | Athena Gtx, Inc. | WVSM Pro (Series) (500-0030-XX) | |
| K232111 | 2024-06-25 | Laerdal Medical AS | NeoBeat, NeoBeat Mini | |
| K233810 | 2024-04-25 | Ge Medical Systems Information Technol | Portrait VSM | |
| K233133 | 2024-04-01 | Talis Clinical, LLC | Talis EMR with Talis +ACG (Talis EMR with +ACG) | |
| K234130 | 2024-03-20 | Ge Medical Systems Information Technol | Portrait Mobile Monitoring Solution consists of: | |
| K233038 | 2024-03-08 | Edan Instruments, Inc. | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3 | |
| K231086 | 2023-12-22 | Analog Devices, Inc. | CPM System | — |
| K230457 | 2023-10-30 | Empatica S.r.l. | Empatica Health Monitoring Platform; EmbracePlus; Em | |
| K230881 | 2023-09-11 | Change Healthcare Israel , Ltd. | Change Healthcare Cardiology Hemodynamics | FDA |
Official FDA classification page: MWI
Classification and pathway per current FDA publications. Data from openFDA (CC0).