Devices descending from K981034
96 later devices reach Silent Night II through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K080427 | Watch-Pat Model 100S-2 | Itamar Medical | 2008 | 25 | — |
| +1 | K000253 | Silent Night V | Sleep Solutions, Inc. | 2000 | 69 | — |
| +2 | K110486 | Accusom | Novasom, Inc. | 2011 | 1 | — |
| +2 | K081982 | Watch-Pat 200S-2 (WP200S-2) | Itamar Medical | 2008 | 24 | — |
| +2 | K070326 | Noga Automated Sleep Study Scoring and Data Management System | Widemed, Ltd. | 2007 | 2 | — |
| +2 | K042745 | Lifescreen Apnea | Del Mar Reynolds Medical, Inc. | 2005 | 63 | 1 |
| +3 | K220012 | BresoDX1 | Bresotec, Inc. | 2022 | 0 | — |
| +3 | K111314 | Morpheus OX | Widemed, Ltd. | 2011 | 0 | — |
| +3 | K110001 | Spacelabs Pathfinder SL Holter Analyzer | Spacelabs Healthcare, Ltd. | 2011 | 6 | 1 |
| +3 | K102567 | Watch-Pat 200S-3 (WP200S-3) | Itamar Medical, Ltd. | 2011 | 23 | — |
| +3 | K083325 | N-600X with SPD, Oximax N-600X | Covidien | 2009 | 53 | — |
| +3 | K081861 | Holter LX Analysis | North East Monitoring, Inc. | 2008 | 0 | — |
| +3 | K073269 | HC1000P Sleep Diagnosis Software System | Hypnocore, Ltd. | 2008 | 0 | — |
| +3 | K070855 | Sleep Quality | Dynadx Corporation | 2008 | 0 | — |
| +4 | K201921 | Spacelabs Lifescreen PRO Analyzer | Spacelabs Healthcare, Ltd. | 2021 | 0 | — |
| +4 | K133859 | Watch-PAT200U (WP200U) | Itamar Medical, Ltd. | 2014 | 22 | — |
| +4 | K121806 | Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System… | Covidien | 2012 | 45 | — |
| +4 | K120462 | Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered… | Inovise Medical, Inc. | 2012 | 3 | — |
| +4 | K120773 | Nellcor Bedside SPO2 Patient Monitoring System | Covidien, LLC | 2012 | 6 | 1 |
| +4 | K111933 | Covidien Nellcor Respiration Rate Software Application, Version 1.0 | Covidien | 2012 | 49 | — |
| +4 | K110569 | Audicor Cpam (Cardiopulmonary Ambulatory Monitor) | Inovise Medical, Inc. | 2011 | 4 | — |
| +5 | K251326 | Respiration Rate algorithm | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +5 | K242798 | Airmod | Heroic Faith International, Ltd. | 2025 | 1 | — |
| +5 | K161579 | Watch-PAT200U | Itamar Medical, Ltd. | 2017 | 20 | — |
| +5 | K153070 | Watch-PAT200U | Itamar Medical, Ltd. | 2016 | 0 | — |
| +5 | K142865 | Nellcor Bedside SpO2 Patient Monitoring System | Covidien, LLC | 2015 | 3 | 1 |
| +5 | K141518 | Nellcor Bedside Respiratory Patient Monitoring System | Covidien | 2015 | 29 | — |
| +5 | K133810 | VC150 Vital Signs Monitor | Innokas Yhtyma | 2014 | 3 | 3 |
| +5 | K131883 | Audicor Cpam with SDB (Accelerometer Based) | Inovise Medical, Inc. | 2014 | 1 | — |
| +5 | K130320 | Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring… | Covidien | 2014 | 40 | — |
| +5 | K130660 | Audicor Cpam with SDB (Single Sensor) | Inovise Medical, Inc. | 2013 | 0 | — |
| +5 | K131085 | Central Venous Pressure System - Mespere Venus 1000 | Mespere Lifesciences, Inc. | 2013 | 1 | — |
| +6 | K243183 | RTMsense Respiratory Monitoring System | Rtm Vital Signs, LLC | 2025 | 0 | — |
| +6 | K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | 2024 | 0 | 1 |
| +6 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022 | 2 | 6 |
| +6 | K203839 | WatchPAT200U (WP200U) | Itamar Medical, Ltd. | 2022 | 4 | — |
| +6 | K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020 | 0 | 1 |
| +6 | K200594 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987, Ltd. | 2020 | 1 | — |
| +6 | K191031 | NightOwl | Ectosense NV | 2020 | 5 | — |
| +6 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019 | 23 | — |
| +6 | K180775 | Watch-PAT300 | Itamar Medical, Ltd. | 2018 | 12 | — |
| +6 | K172482 | The Nellcor pulse oximetry monitor interface cable | Covidien | 2017 | 1 | — |
| +6 | K152659 | V10 | Mediana Co., Ltd. | 2016 | 2 | — |
| +6 | K152043 | Diagnostic Station DS20 | Schiller AG | 2016 | 1 | — |
| +6 | K151433 | AUDICOR CA300/CC100 Analyzer with SDB | Inovise Medical, Inc. | 2016 | 0 | — |
| +6 | K151776 | Central Venous Pressure System | Mespere Lifesciences, Inc. | 2015 | 0 | — |
| +6 | K150272 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987, Ltd. | 2015 | 4 | 1 |
| +6 | K140430 | 740 Select | Cas Medical Systems, Inc. | 2014 | 1 | — |
| +7 | K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | 2026 | 0 | — |
| +7 | K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2025 | 0 | — |
| +7 | K242224 | Happy Health Home Sleep Test | Happy Health, Inc. | 2025 | 0 | — |
| +7 | K241086 | Avidhrt Sense SpO2 | Avidhrt, Inc. | 2025 | 0 | — |
| +7 | K214115 | MightySat -OTC | Masimo Corporation | 2024 | 1 | — |
| +7 | K231546 | Somfit | Compumedics Limited | 2023 | 1 | — |
| +7 | K222331 | WatchPAT300 (WP300) | Itamar Medical, Ltd. | 2022 | 3 | — |
| +7 | K213911 | Microstream CO2 NanoPod | Covidien, LLC | 2022 | 0 | — |
| +7 | K213518 | CARESCAPE CO2 Microstream parameter | Covidien, LLC | 2022 | 0 | — |
| +7 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | 5 | — |
| +7 | K211400 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2022 | 0 | — |
| +7 | 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 | — |
| +7 | K213463 | NightOwl | Ectosense NV | 2021 | 3 | — |
| +7 | K201179 | GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable | Covidien, LLC | 2020 | 0 | — |
| +7 | K183559 | WatchPAT ONE | Itamar Medical, Ltd. | 2019 | 5 | — |
| +7 | K181352 | Loop System | Spry Health, Inc. | 2019 | 10 | — |
| +7 | K170497 | V10 | Mediana Co., Ltd. | 2017 | 1 | 1 |
| +7 | K170182 | Cardiovit FT-1 | Schiller AG | 2017 | 0 | — |
| +7 | K150620 | 740 Select | Cas Medical Systems, Inc. | 2015 | 0 | 1 |
| +8 | K252383 | Somfit D | Compumedics Limited | 2025 | 0 | — |
| +8 | K211498 | Nonin OTC Pulse Oximeter Model 3250 | Nonin Medical, Inc. | 2024 | 0 | — |
| +8 | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | 2 | — |
| +8 | K232445 | CSF-4 (CSF-4) | Cardiacsense | 2024 | 0 | — |
| +8 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | 4 | — |
| +8 | K223675 | WatchPAT ONE (WP1) | Itamar Medical, Ltd. | 2023 | 2 | — |
| +8 | K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | 1 | — |
| +8 | 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 | — |
| +8 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | 7 | — |
| +8 | K220351 | Polso Watch | Chronisense Medical, Ltd. | 2022 | 0 | — |
| +8 | K220095 | ANNE Sleep | Sibel, Inc. | 2022 | 4 | — |
| +8 | K220028 | NightOwl | Ectosense NV | 2022 | 2 | — |
| +9 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus… | Empatica S.r.l. | 2026 | 0 | — |
| +9 | K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | 2026 | 0 | — |
| +9 | K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | 2026 | 0 | — |
| +9 | K252981 | EmbraceMini | Empatica S.r.l. | 2025 | 1 | — |
| +9 | K250460 | WatchPAT400 (WP400) | Itamar Medical, Ltd. | 2025 | 1 | — |
| +9 | K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2025 | 0 | — |
| +9 | K243268 | TipTraQ (TTQ001) | Pranaq Pte., Ltd. | 2025 | 0 | — |
| +9 | K241066 | BB-613-BPM | Biobeat Technologies, Ltd. | 2025 | 0 | — |
| +9 | K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024 | 0 | — |
| +9 | K240285 | Huxley SANSA Home Sleep Apnea Test (1000-00) | Huxley Medical | 2024 | 3 | — |
| +9 | K232915 | EpiMonitor | Empatica S.r.l. | 2024 | 1 | — |
| +9 | K222579 | Belun Sleep System BLS-100 | Belun Technology Company Limited | 2023 | 0 | — |
| +10 | K254042 | WatchPAT SW | Itamar Medical, Ltd. | 2026 | 0 | — |
| +10 | K250515 | EpiMonitor | Empatica S.r.l. | 2025 | 0 | — |
| +10 | K244027 | Sansa Hsat | Huxley Medical | 2025 | 2 | — |
| +11 | K253148 | RX-1 Sleep | Vivaquant, Inc. Dba Rhythm Express | 2026 | 0 | — |
| +11 | K252497 | Sansa Hsat | Huxley Medical | 2025 | 0 | — |