Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MWI — Predicate Candidate Screening
306 FDA 510(k) clearances under this product code; the 50 most recent screened below.
115 daysmedian FDA review time
282 days90th percentile
306clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-02 | Midmark Corporation | 2026-06-12 | 259 | 0 |
| K253436 | c-med0 alpha | Cosinuss GmbH | 2026-04-30 | 211 | 0 |
| K250135 | WAVE Clinical Platform (2.0.000) | Baxter Healthcare Corp/ Excel Medical | 2026-01-16 | 364 | 0 |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | Fysicon BV | 2025-08-27 | 433 | 0 |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica C | Empatica S.r.l. | 2025-06-06 | 268 | 0 |
| K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | 2025-02-14 | 226 | 0 |
| K243146 | iCare APP | Ihealth Labs, Inc. | 2025-02-03 | 126 | 0 |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor | Welch Allyn, Inc. | 2024-12-20 | 217 | 1 |
| K243216 | Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) | Analog Devices | 2024-12-10 | 68 | 0 |
| K233446 | AMC Health CareConsole | Amc Health | 2024-09-27 | 344 | 0 |
| K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024-09-24 | 239 | 0 |
| K233354 | WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. | 2024-06-26 | 271 | 0 |
| K232111 | NeoBeat, NeoBeat Mini | Laerdal Medical AS | 2024-06-25 | 347 | 0 |
| K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | 2024-04-25 | 147 | 1 |
| K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC | 2024-04-01 | 187 | 0 |
| K234130 | Portrait™ Mobile Monitoring Solution consists of: • Portrait | Ge Medical Systems Information Technologies, Inc. | 2024-03-20 | 83 | 2 |
| K233038 | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s | Edan Instruments, Inc. | 2024-03-08 | 165 | 1 |
| K231086 | CPM System | Analog Devices, Inc. | 2023-12-22 | 249 | 0 |
| K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica C | Empatica S.r.l. | 2023-10-30 | 251 | 0 |
| K230881 | Change Healthcare Cardiology Hemodynamics™ | Change Healthcare Israel , Ltd. | 2023-09-11 | 165 | 2 |
| K230626 | Portrait™ Central Viewer Application (Portrait CV A01), Port | Ge Medical Systems Information Technologies, Inc. | 2023-08-11 | 157 | 0 |
| K220117 | ARC Intensive Care Information System (ARC System) | Ordinatrum Solutions | 2023-06-06 | 508 | 0 |
| K230214 | Huma RPM (RPM) | Medopad, Inc. | 2023-06-02 | 127 | 0 |
| K222330 | The Heart Seat | Casana Care, Inc. | 2023-04-24 | 265 | 0 |
| K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Acce | Masimo Corporation | 2023-03-06 | 602 | 0 |
| K221267 | VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vi | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2022-12-15 | 227 | 0 |
| K221113 | Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-12-02 | 231 | 0 |
| K212473 | Welch Allyn Connex Central Station | Welch Allyn, Inc. | 2022-10-28 | 448 | 0 |
| K212975 | MedWand | Medwand Solutions, Inc. | 2022-07-22 | 308 | 0 |
| K213335 | Capsule Surveillance System | Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. | 2022-01-14 | 100 | 0 |
| K211754 | Vital Signs Monitor | Beijing Choice Electronic Technology Co., Ltd. | 2021-11-15 | 161 | 0 |
| K210204 | Capsule Vitals Plus Patient Monitoring System | Capsule Technologie Sas | 2021-10-19 | 266 | 0 |
| K211475 | Vital Signs Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-10-05 | 146 | 0 |
| K212227 | Philips MR Patient Care Portal | Invivo Corporation | 2021-09-30 | 76 | 1 |
| K210086 | Vitals360 Multi-Vitals Mobile Monitor | Vocare, Inc. | 2021-05-20 | 127 | 0 |
| K202375 | ZOLL Propaq M | ZOLL Medical Corporation | 2021-03-09 | 201 | 0 |
| K200160 | 740 SafeSAT | Zoe Medical, Inc. | 2021-02-15 | 390 | 0 |
| K201635 | MouthLab Vital Signs Monitoring System | Multisensor Diagnostics (Dba Aidar Health) | 2021-02-06 | 235 | 0 |
| K202892 | Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s | Edan Instruments, Inc. | 2021-01-28 | 122 | 1 |
| K202306 | T3 Platform software | Etiometry, Inc. | 2020-11-25 | 103 | 0 |
| K193626 | Masimo Rad-97 Pulse CO-Oximeter and Accessories | Masimo Corporation | 2020-08-10 | 228 | 0 |
| K200856 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie Sas | 2020-07-10 | 100 | 0 |
| K200141 | Oxi-W System | Ld Technology, LLC | 2020-04-27 | 97 | 0 |
| K191882 | Masimo Centroid System | Masimo Corporation | 2020-04-22 | 282 | 0 |
| K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radi | Masimo Corporation | 2020-02-27 | 94 | 0 |
| K191989 | WVSM (Wireless Vital Signs Monitor) RWC + miniCap | Athena Gtx | 2020-01-29 | 188 | 0 |
| K192004 | Eko Analysis Software | Eko Devices, Inc. | 2020-01-15 | 173 | 0 |
| K191059 | Masimo Rad-97 and Accessories | Masimo Corporation | 2019-12-27 | 249 | 0 |
| K190273 | T3 Platform software | Etiometry, Inc. | 2019-12-08 | 303 | 0 |
| K183687 | LifeWindow LW8 Lite | Digicare Biomedical Technology, Inc. | 2019-09-25 | 271 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda