Devices descending from K991823
785 later devices reach N-395 Pulse Oximeter, Model N-395 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +3 | K211140 | Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse… | Stryker Sustainability Solutions | 2022 | 2 | — |
| +3 | K192322 | T-Stat 2.0 Microvascular Tissue Oximeter | Spectros Corporation | 2019 | 0 | — |
| +3 | K191018 | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors | Surgical Instrument Service and Savings, Inc. | 2019 | 0 | — |
| +3 | K181738 | Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors | Surgical Instrument Service and Savings Inc (Dba Medline | 2019 | 1 | — |
| +3 | K171423 | Nasal Alar SpO2 Sensor | Xhale, Inc. | 2017 | 1 | 1 |
| +3 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | 2 | — |
| +3 | K161909 | IQvitals Zone | Midmark Corporation | 2016 | 1 | 4 |
| +3 | K160582 | WiCap | Athena Gtx | 2016 | 0 | — |
| +3 | K152043 | Diagnostic Station DS20 | Schiller AG | 2016 | 1 | — |
| +3 | K152258 | T3 Software | Etiometry, Inc. | 2016 | 16 | — |
| +3 | K151940 | Thora-3Di, Model T-01 | Pneumacare Limited | 2016 | 3 | — |
| +3 | K150272 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987, Ltd. | 2015 | 4 | 1 |
| +3 | K150975 | Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2… | Philips Medizin Systeme Boeblingen GmbH | 2015 | 34 | 1 |
| +3 | K142512 | Personalized Physiology Analytics Engine software | Vgbio, Inc (Dba Physiq) | 2015 | 3 | — |
| +3 | K142865 | Nellcor Bedside SpO2 Patient Monitoring System | Covidien, LLC | 2015 | 3 | 1 |
| +3 | K141460 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2015 | 4 | — |
| +3 | K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | Fukuda Denshi USA, Inc. | 2015 | 0 | — |
| +3 | K141518 | Nellcor Bedside Respiratory Patient Monitoring System | Covidien | 2015 | 29 | — |
| +3 | K132407 | Vital Signs Patch System (in Short VSP) | Lifewatch Technologies, Ltd. | 2014 | 1 | — |
| +3 | K141542 | Nellcor Portable SPO2 Patient Monitoring System ( Npspms ) | Covidien, LLC | 2014 | 0 | — |
| +3 | K133973 | Tempus Pro with Enhanced Features | Remote Diagnostic Technologies, Ltd. | 2014 | 3 | — |
| +3 | K134014 | Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe) | Remote Diagnostic Technologies, Ltd. | 2014 | 3 | — |
| +3 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and… | Vitalconnect, Inc. | 2014 | 70 | — |
| +3 | K140430 | 740 Select | Cas Medical Systems, Inc. | 2014 | 1 | — |
| +3 | K140049 | Moves SLC | Thornhill Research, Inc. | 2014 | 1 | — |
| +3 | K133988 | Tempus Pro Extended Features | Remote Diagnostic Technologies, Ltd. | 2014 | 3 | — |
| +3 | K130740 | Nightingale Monitoring System | Zoe Medical, Inc. | 2013 | 3 | — |
| +3 | K124038 | Bedside Paediatric Early Warning System (Bedsidepews) | Bedside Clinical Systems, Inc. | 2013 | 2 | — |
| +3 | K130411 | 740 Select | Cas Medical Systems, Inc. | 2013 | 6 | — |
| +3 | K123556 | Mortara Surveyor Patient Monitor | Mortara Instrument, Inc. | 2013 | 2 | 1 |
| +3 | K123309 | Giraffe and Panda Warmers | Ohmeda Medical | 2013 | 0 | Class I |
| +3 | K112877 | Comen Multi-Parameter Patient Monitor | Goldway (Us), Inc. | 2012 | 1 | — |
| +3 | K122036 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 20 | 2 |
| +3 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | 65 | — |
| +3 | K121912 | E1 Ear Sensors | Masimo Corporation | 2012 | 4 | — |
| +3 | K120366 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2012 | 46 | — |
| +3 | K120173 | Patient Monitor | Edan Instruments, Inc. | 2012 | 10 | — |
| +3 | K112761 | Zoll Propaq MD | Zoll Medical Corporation, World Wide Headquarters | 2012 | 0 | 1 |
| +3 | K111933 | Covidien Nellcor Respiration Rate Software Application, Version 1.0 | Covidien | 2012 | 49 | — |
| +3 | K113596 | Masimo Set Reusable Oximetry Sensors | Masimo Corporation | 2012 | 0 | — |
| +3 | K113623 | Patient Monitor | Edan Instruments, Inc. | 2012 | 15 | 2 |
| +3 | K111773 | Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and Neonate | Renu Medical, Inc. | 2011 | 0 | — |
| +3 | K112190 | Patient Monitor | Mediana Co., Ltd. | 2011 | 0 | — |
| +3 | K111621 | Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry Sensors | Masimo Corporation | 2011 | 38 | — |
| +3 | K111888 | Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry Sensors | Masimo Corporation | 2011 | 59 | — |
| +3 | K110723 | M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry Sensors | Masimo Corporation | 2011 | 0 | — |
| +3 | K103631 | Sleepminder Breathing Frequency Indicator | Biancamed Limited | 2011 | 1 | — |
| +3 | K110953 | Visensia, Visensia with Alert | Obs Medical | 2011 | 17 | — |
| +3 | K103584 | Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and… | Shenzhen Envisen Industry Co. Limited | 2011 | 0 | — |
| +3 | K110015 | Vitalsens, Aingeal, V-Pod | Intelesens Limited | 2011 | 4 | — |
| +3 | K103166 | Cheetah Reliant | Cheetah Medical, Inc. | 2011 | 1 | — |
| +3 | K094030 | Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000… | Cas Medical Systems, Inc. | 2010 | 53 | — |
| +3 | K102715 | Regional Oximeter | Nonin Medical, Inc. | 2010 | 53 | — |
| +3 | K100040 | Bioharness | Zephyr Technology Corporation | 2010 | 3 | — |
| +3 | K102468 | Zoll Propaq MD | Zoll Medical Corporation, World Wide Headquarters | 2010 | 9 | — |
| +3 | K101674 | WVSM (Wireless Vital Signs Monitor), Model 5.0 | Athena Gtx | 2010 | 17 | — |
| +3 | K100773 | Kai Spot Model KMS 200 | Kai Medical, Inc. | 2010 | 0 | — |
| +3 | K094046 | LNCS Oximetry Sensors, Reprocessed LNCS Oximetry Sensors | Masimo Corporation | 2010 | 0 | — |
| +3 | K093802 | Ultraview DM3 Monitor | Zoe Medical, Inc. | 2010 | 0 | 2 |
| +3 | K093016 | Vital Signs Monitor | Shenzhen Creative Industry Co., Ltd. | 2010 | 16 | — |
| +3 | K093501 | Elance Vital Signs Monitor and Elance Central Station | Spacelabs Medical, Inc. | 2009 | 1 | 2 |
| +3 | K091787 | Model 6000 Two Parameter Bedside Monitor | Ivy Biomedical Systems, Inc. | 2009 | 0 | — |
| +3 | K091459 | Philips NM3 Monitor, Model 7900 | Respironics Novametrix, LLC | 2009 | 5 | 4 |
| +3 | K083821 | Vital Signs Monitor | Edan Instruments, Inc. | 2009 | 39 | — |
| +3 | K090360 | Philips M3001A Multi Measurement Server | Philips Medizin Systeme Boblingen GmbH | 2009 | 84 | — |
| +3 | K090697 | Modification to: Giraffe and Panda Warmer | Ohmeda Medical | 2009 | 1 | Class I |
| +3 | K090801 | Electronic House Call | Express MD Solutions, LLC | 2009 | 3 | — |
| +3 | K083325 | N-600X with SPD, Oximax N-600X | Covidien | 2009 | 53 | — |
| +3 | K082599 | Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500AT | Cnsystem Medizintechnik AG | 2008 | 25 | — |
| +3 | K081891 | Fukuda Denshi Dynascope Model DS-7000/7000M Patient Monitor | Fukuda Denshi USA, Inc. | 2008 | 3 | — |
| +3 | K081238 | Reprocessed Masimo Pulse Oximeter Sensors | Ascent Healthcare Solutions | 2008 | 3 | — |
| +3 | K080652 | Mercury VCO2 Module with Capnostat 5 | Respironics Novametrix, LLC | 2008 | 1 | 4 |
| +3 | K073407 | Pacifica | Or-Nim Medical, Ltd. | 2008 | 1 | — |
| +3 | K073462 | Modification to Dash 3000, 4000, 5000 Monitor and Accessories | Ge Medical Systems Information Technologies | 2008 | 8 | 9 |
| +3 | K072976 | Model 250CX Series Maternal/Fetal Monitor | GE Healthcare | 2007 | 0 | — |
| +3 | K073203 | Carescape V100 | Ge Medical Systems Information Technologies | 2007 | 20 | — |
| +3 | K072516 | Midmark Diagnostics Iqmark Vital Signs Monitor | Midmark Diagnostics Group | 2007 | 2 | — |
| +3 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | 197 | — |
| +3 | K071606 | Biosign Central Station | Obs Medical | 2007 | 0 | — |
| +3 | K072157 | Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) | Ohmeda Medical | 2007 | 2 | 1 |
| +3 | K063087 | Modification to Model 750 Series Monitor | Cas Medical Systems, Inc. | 2006 | 0 | — |
| +3 | K060675 | Envitec Reusable Softip Y SPO2 Sensors | Envitec-Wismar GmbH | 2006 | 4 | — |
| +3 | K061112 | Conmed PRO2 Pulse Reflectance Oximeter, Model Pro-M | Conmed Corporation | 2006 | 0 | — |
| +3 | K051907 | Innocor | Innovision A/S | 2006 | 4 | — |
| +3 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00 | Philips Medizin Systeme Boeblingen GmbH | 2006 | 233 | — |
| +3 | K051352 | Oximax NPB-40 Handheld Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2005 | 28 | — |
| +3 | K051375 | Vital Signs Monitor | Mediana Co., Ltd. | 2005 | 3 | — |
| +3 | K033028 | Anefin, Model 100 | Axon Medical | 2005 | 1 | — |
| +3 | K050605 | Spacelabs Medical Multiparameter Module 91496 | Spacelabs Medical, Inc. | 2005 | 1 | 1 |
| +3 | K042007 | Zoll E Series Defibrillator | Zoll Medical Corp | 2005 | 64 | 3 |
| +3 | K050068 | Lnopv AD-L and PD-L Oximetry Sensors | Masimo Corporation | 2005 | 0 | — |
| +3 | K041644 | Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible)… | Elekon Industries U.S.A., Inc. | 2004 | 0 | — |
| +3 | K041450 | Modification to Nico with Mars, Model 7300 | Respironics Novametrix, Inc. | 2004 | 0 | 1 |
| +3 | K041412 | Esprit Ventilator with Nico-Esprit Interface Option, Model V1000 | Respironics California, Inc. | 2004 | 0 | 6 |
| +3 | K032551 | Masimo Lnop-TF-I Resuable Transflectance Sensor | Masimo Corp. | 2004 | 1 | — |
| +3 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | 290 | — |
| +3 | K030611 | Modification to Suzanne Portable Polysomnograph System | Nellcor Puritan Bennett (Melville), Ltd. | 2003 | 0 | — |
| +4 | K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Midmark Corporation | 2026 | 0 | — |
| +4 | K251326 | Respiration Rate algorithm | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +4 | K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar… | Philips Medizin Systeme | 2026 | 0 | — |