Devices descending from K021389
156 later devices reach Biological Sound Monitor (BSM) Sensor through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +7 | K201746 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies Limited | 2020 | 0 | 7 |
| +7 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019 | 23 | — |
| +7 | K171121 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2017 | 16 | — |
| +7 | K170168 | Masimo Rad-97 and Accessories | Masimo Corporation | 2017 | 14 | — |
| +8 | K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025 | 0 | — |
| +8 | K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot… | Philips Medizin Systeme Böblingen GmbH | 2025 | 1 | — |
| +8 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere… | Edwards Lifesciences | 2025 | 2 | 1 |
| +8 | K241086 | Avidhrt Sense SpO2 | Avidhrt, Inc. | 2025 | 0 | — |
| +8 | K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024 | 0 | — |
| +8 | K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024 | 1 | — |
| +8 | K232915 | EpiMonitor | Empatica S.r.l. | 2024 | 1 | — |
| +8 | K214115 | MightySat -OTC | Masimo Corporation | 2024 | 1 | — |
| +8 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | 4 | — |
| +8 | K231506 | Current Health System | Current Health, Ltd. | 2023 | 0 | — |
| +8 | K230626 | Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services… | Ge Medical Systems Information Technologies, Inc. | 2023 | 2 | 1 |
| +8 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | 5 | — |
| +8 | K211400 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2022 | 0 | — |
| +8 | K211632 | Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102… | Shenzhen Narig Bio-Medical Technology Co., Ltd. | 2022 | 1 | — |
| +8 | K200856 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie Sas | 2020 | 1 | — |
| +8 | K191882 | Masimo Centroid System | Masimo Corporation | 2020 | 3 | — |
| +8 | K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and… | Masimo Corporation | 2020 | 7 | — |
| +8 | K180903 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2019 | 0 | — |
| +8 | K181352 | Loop System | Spry Health, Inc. | 2019 | 10 | — |
| +8 | K180046 | Masimo Rad-97 and Accessories | Masimo Corporation | 2018 | 13 | 1 |
| +9 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus… | Empatica S.r.l. | 2026 | 0 | — |
| +9 | K253417 | Masimo Root Monitoring System | Masimo Corporation | 2026 | 0 | — |
| +9 | K261367 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2026 | 0 | — |
| +9 | K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | 2026 | 0 | — |
| +9 | K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +9 | K252981 | EmbraceMini | Empatica S.r.l. | 2025 | 1 | — |
| +9 | K253034 | HemoSphere Stream Module | Edwards Lifesciences | 2025 | 0 | — |
| +9 | K250515 | EpiMonitor | Empatica S.r.l. | 2025 | 0 | — |
| +9 | K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2025 | 0 | — |
| +9 | K211498 | Nonin OTC Pulse Oximeter Model 3250 | Nonin Medical, Inc. | 2024 | 0 | — |
| +9 | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | 2 | — |
| +9 | K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse… | Stryker Sustainability Solutions | 2024 | 0 | — |
| +9 | K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024 | 0 | — |
| +9 | K240251 | ANNE Chest | Sibel Health, Inc. | 2024 | 0 | — |
| +9 | K232445 | CSF-4 (CSF-4) | Cardiacsense | 2024 | 0 | — |
| +9 | K234130 | Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application… | Ge Medical Systems Information Technologies, Inc. | 2024 | 0 | 4 |
| +9 | K223498 | Radius VSM and Accessories | Masimo Corporation | 2023 | 1 | 2 |
| +9 | K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories | Masimo Corporation | 2023 | 0 | — |
| +9 | K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | 1 | — |
| +9 | K222213 | Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103… | Unimed Medical Supplies, Inc. | 2022 | 0 | — |
| +9 | K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse… | Stryker Sustainability Solutions | 2022 | 1 | — |
| +9 | K220351 | Polso Watch | Chronisense Medical, Ltd. | 2022 | 0 | — |
| +9 | K210204 | Capsule Vitals Plus Patient Monitoring System | Capsule Technologie Sas | 2021 | 0 | — |
| +9 | K201770 | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor | Masimo Corporation | 2020 | 1 | 2 |
| +9 | K191059 | Masimo Rad-97 and Accessories | Masimo Corporation | 2019 | 0 | — |
| +9 | K183697 | Masimo Rad-97 and Accessories | Masimo Corporation | 2019 | 9 | — |
| +10 | K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | 2026 | 0 | — |
| +10 | K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | 2026 | 0 | — |
| +10 | K250757 | Radius VSM and Accessories | Masimo Corporation | 2025 | 0 | — |
| +10 | K241066 | BB-613-BPM | Biobeat Technologies, Ltd. | 2025 | 0 | — |
| +10 | K231531 | Pediarity™ | Hinlab, Inc. | 2023 | 0 | — |
| +10 | K193626 | Masimo Rad-97 Pulse CO-Oximeter and Accessories | Masimo Corporation | 2020 | 1 | — |