Devices descending from K001085
197 later devices reach Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +6 | K242455 | AViTA Pulse Oximeter (SP62B) | Avita Corporation | 2025 | 0 | — |
| +6 | K241090 | Evie Med Ring | Movano Inc. Dba Movano Health | 2024 | 0 | — |
| +6 | K241397 | Hinscope | Hinlab Sas | 2024 | 0 | — |
| +6 | K234110 | Belun Ring BLR-200 (BLR-200) | Belun Technology Company Limited | 2024 | 0 | — |
| +6 | K240808 | Pulse Oximeter (WS20A) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2024 | 0 | — |
| +6 | K231288 | Vyvo | Vyvo Technology Corp.(Vt) | 2024 | 0 | — |
| +6 | K214115 | MightySat -OTC | Masimo Corporation | 2024 | 1 | — |
| +6 | K230587 | Wrist Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2023 | 0 | — |
| +6 | K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2023 | 1 | — |
| +6 | K221361 | circul™ pro Ring | Bodimetrics, LLC | 2023 | 1 | — |
| +6 | K222525 | Alveoair Digital Spirometer | Roundworks Technologies Private Limited | 2023 | 0 | — |
| +6 | K211143 | Pulse Oximeter | Shenzhen Brav Electronic Technologies Co., Ltd. | 2023 | 0 | — |
| +6 | K213754 | SpiroHome Personal, SpiroHome Clinic | Inofab Saglik Teknolojileri A.S | 2023 | 0 | — |
| +6 | K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | 2023 | 1 | — |
| +6 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | 7 | — |
| +6 | K222550 | Current Health System | Current Health, Ltd. | 2022 | 1 | — |
| +6 | K221979 | Pulse Oximeter (Model C101A2, C101B1, C101A3) | Shenzhen Imdk Medical Technology Co., Ltd. | 2022 | 0 | — |
| +6 | K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022 | 1 | — |
| +6 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | 5 | — |
| +6 | K211400 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2022 | 0 | — |
| +6 | 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 | — |
| +6 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | 8 | — |
| +6 | K210274 | Fingertip Pulse Oximeter | Zhuhai Linte Medical Instrument Co., Ltd. | 2021 | 0 | — |
| +6 | K202743 | Med-Link Temp-pulse Oximeter | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2021 | 0 | — |
| +6 | K202837 | GoSpiro | Monitored Therapeutics, Inc. | 2020 | 0 | — |
| +6 | K201294 | Pulse Oximeter | Guangdong Long Yao Electronic Technology Co., Ltd. | 2020 | 0 | — |
| +6 | K201562 | Spirotrac | Vitalograph Ireland, Ltd. | 2020 | 0 | — |
| +6 | K200414 | Pulse Oximeter | Shenzhen Aeon Technology Co., Ltd. | 2020 | 1 | — |
| +6 | K190561 | NICU V'02 | Cosmed Nordic Aps | 2020 | 0 | — |
| +6 | K192004 | Eko Analysis Software | Eko Devices, Inc. | 2020 | 4 | — |
| +6 | K191088 | Checkme O2 Pulse Oximeter | Shenzhen Viatom Technology Co., Ltd. | 2019 | 2 | — |
| +6 | K191430 | Pulse Oximeter | Shenzhen Yimi Life-Technology Co., Ltd. | 2019 | 7 | — |
| +6 | K182401 | B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared… | Amzetta Technologies Private Limited | 2019 | 0 | — |
| +6 | K190792 | BB-613WP | Biobeat Technologies, Ltd. | 2019 | 12 | — |
| +6 | K181352 | Loop System | Spry Health, Inc. | 2019 | 10 | — |
| +6 | K180685 | AS-3XX Series Fingertip Pulse Oximeter | Xiamen Acurio Instruments Co., Ltd. | 2018 | 0 | — |
| +6 | K181503 | Fingertip Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2018 | 6 | — |
| +6 | K163135 | Finger Pulse Oximeter | Shenzhen Fitfaith Technology Co.,Ltd | 2017 | 4 | — |
| +6 | K152091 | Fingertip Pulse Oximeter | Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. | 2016 | 0 | — |
| +6 | K152089 | Wrist Pulse Oximeter | Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. | 2016 | 0 | — |
| +6 | K160956 | LD-Oxi system | Ld Technology, LLC | 2016 | 2 | — |
| +6 | K142642 | Vitalograph Model 6600 Compact | Vitalograph (Ireland), Ltd. | 2015 | 0 | — |
| +6 | K132407 | Vital Signs Patch System (in Short VSP) | Lifewatch Technologies, Ltd. | 2014 | 1 | — |
| +6 | K130056 | Patient Monitor | Ld Technology, LLC | 2013 | 0 | — |
| +6 | K102047 | Lci Option for Innocor | Innovision A/S | 2011 | 0 | 1 |
| +7 | K250837 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | 2025 | 0 | — |
| +7 | K250415 | G0 Blood Pressure Monitoring System (G0) | Aktiia SA | 2025 | 1 | — |
| +7 | K242876 | Pulse Oximeter ( PO2, PO2A, PO2B) | Shenzhen Viatom Technology Co., Ltd. | 2025 | 0 | — |
| +7 | K241066 | BB-613-BPM | Biobeat Technologies, Ltd. | 2025 | 0 | — |
| +7 | K211498 | Nonin OTC Pulse Oximeter Model 3250 | Nonin Medical, Inc. | 2024 | 0 | — |
| +7 | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | 2 | — |
| +7 | K240092 | Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112… | Shenzhen Yimi Life Technology Co., Ltd. | 2024 | 0 | — |
| +7 | K232975 | Pulse Oximeter (MD300C228) | Beijing Choice Electronic Technology Co., Ltd. | 2024 | 0 | — |
| +7 | K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024 | 0 | — |
| +7 | K232445 | CSF-4 (CSF-4) | Cardiacsense | 2024 | 0 | — |
| +7 | K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024 | 1 | — |
| +7 | K232915 | EpiMonitor | Empatica S.r.l. | 2024 | 1 | — |
| +7 | K232053 | SimpleSense-BP, SimpleSense-BP Software Application | Nanowear, Inc. | 2023 | 0 | — |
| +7 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | 4 | — |
| +7 | K231506 | Current Health System | Current Health, Ltd. | 2023 | 0 | — |
| +7 | K230172 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2023 | 1 | — |
| +7 | K222658 | Accurate 24 Non-invasive blood pressure monitor | Accurate Meditech, Inc. | 2023 | 2 | — |
| +7 | K223765 | ATEC Lateral Navigation Instruments | Alphatec Spine, Inc. | 2023 | 0 | 2 |
| +7 | K220101 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2023 | 0 | — |
| +7 | K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | 1 | — |
| +7 | 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 | — |
| +7 | K213984 | Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) | Shenzhen Zhengkang Technology Co., Ltd. | 2022 | 0 | — |
| +7 | K220351 | Polso Watch | Chronisense Medical, Ltd. | 2022 | 0 | — |
| +7 | K203812 | Oxyfit Pulse Oximeter | Shenzhen Viatom Technology Co., Ltd. | 2022 | 0 | — |
| +7 | K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 2022 | 3 | — |
| +7 | K212665 | Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse… | Huizhou Xiaoou Technology Co., Ltd. | 2022 | 1 | — |
| +7 | K213515 | WesperO2 | Wesper, Inc. | 2022 | 0 | — |
| +7 | K203854 | Pulse Oximeter | Shenzhen Hexin Zondan Medical Equipment Co., Ltd. | 2021 | 1 | — |
| +7 | K202324 | Fingertip Pulse Oximeter | Shenzhen Bsx Technology Electronics Co., Ltd. | 2020 | 0 | — |
| +7 | K202173 | Pulse Oximeter | Shenzhen AOJ Medical Technology Co., Ltd. | 2020 | 1 | — |
| +7 | K201384 | Pulse Oximeter | Shenzhen Raysintone Technology Co., Ltd. | 2020 | 0 | — |
| +7 | K200141 | Oxi-W System | Ld Technology, LLC | 2020 | 1 | — |
| +7 | K151835 | Vital Signs Patch System | Lifewatch Technologies, Ltd. | 2016 | 0 | — |
| +8 | K254000 | Happy Health Blood Pressure Monitor | Happy Health, Inc. | 2026 | 0 | — |
| +8 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus… | Empatica S.r.l. | 2026 | 0 | — |
| +8 | K261367 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2026 | 0 | — |
| +8 | K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | 2026 | 0 | — |
| +8 | K253306 | BioTracker 2.0 | Biotracker, LLC | 2026 | 0 | — |
| +8 | K253152 | BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) | Biozen, LLC | 2026 | 0 | — |
| +8 | K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | 2026 | 0 | — |
| +8 | K252981 | EmbraceMini | Empatica S.r.l. | 2025 | 1 | — |
| +8 | K251494 | Eko Foundation Analysis Software with Transformers (EFAST) | Eko Health, Inc. | 2025 | 0 | — |
| +8 | K250515 | EpiMonitor | Empatica S.r.l. | 2025 | 0 | — |
| +8 | K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2025 | 0 | — |
| +8 | K242352 | Accurate Mini Non-invasive blood pressure monitor (AMB-001) | Accurate Meditech, Inc. | 2025 | 0 | — |
| +8 | K243049 | Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2025 | 0 | — |
| +8 | K232520 | Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B… | Shenzhen Smallsignal Technology Co., Ltd. | 2024 | 0 | — |
| +8 | K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024 | 0 | — |
| +8 | K240901 | Stethophone | Sparrow Acoustics, Inc. | 2024 | 1 | — |
| +8 | K230277 | Pulse Oximeter (Model OHT60,OXH78) | Cofoe Medical Technology Co., Ltd. | 2024 | 0 | — |
| +8 | K213430 | Fingertip Pulse Oximeter | Shenzhen Witleaf Medical Electronics Co., Ltd. | 2022 | 0 | — |
| +9 | K252595 | Stethophone Pro | Sparrow Acoustics, Inc. | 2025 | 0 | — |