Devices descending from K984407
115 later devices reach Bipap Harmony S/T, Model 1001445 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K053168 | Bipap Focus | Respironics (Ireland) Limited | 2006 | 11 | 1 |
| +1 | K022132 | Servo Ventilator System, Model 64 87 800 E407E | Siemens Medical Solutions USA, Inc. | 2002 | 102 | — |
| +2 | K093094 | Vela Ventilator | Cardinal Health 207, Inc. | 2010 | 2 | — |
| +2 | K071560 | Provent Nasal Dilator, Model BR2 | Ventus Medical, Inc. | 2008 | 10 | — |
| +2 | K073069 | Modification to Avea Ventilator | Viasys Respiratory Care, Inc. | 2008 | 3 | Class I |
| +2 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | 53 | — |
| +2 | K040221 | Servo-I Ventilator System, Model 64 87 800 E407E | Maquet Critical Care AB | 2004 | 75 | 1 |
| +2 | K034040 | Esprit Ventilator, Model V1000 | Respironics, Inc. | 2004 | 1 | Class I |
| +2 | K030341 | Modification to Inspiration Ventilator System | eVent Medical, Ltd. | 2004 | 4 | — |
| +3 | K111549 | Attune Sleep Apnea System | Apnicure, Inc. | 2012 | 5 | — |
| +3 | K101643 | Model LTV 1100 Ventilator | Care Fusion | 2011 | 1 | — |
| +3 | K102404 | Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea… | Ventus Medical, Inc. | 2010 | 2 | — |
| +3 | K090398 | Provent Professional Sleep Apnea Therapy | Ventus Medical, Inc. | 2009 | 3 | 1 |
| +3 | K062793 | Servo-I Ventilator System, Model 64 87 800 E407E; Nava Option | Maquet Critical Care AB | 2007 | 0 | — |
| +3 | K061090 | Galileo Gold Asv | Hamilton Medical AG | 2006 | 36 | — |
| +3 | K052863 | Raphael Color | Hamilton Medical AG | 2006 | 1 | 3 |
| +3 | K051550 | Inspiration Ventilator System | eVent Medical, Ltd. | 2005 | 3 | 1 |
| +3 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 51 | 1 |
| +3 | K041223 | Modification to Servo-I Ventilator System, Model 64 87 800 E407E | Maquet Critical Care AB | 2004 | 73 | Class I |
| +3 | K041412 | Esprit Ventilator with Nico-Esprit Interface Option, Model V1000 | Respironics California, Inc. | 2004 | 0 | 6 |
| +4 | K201082 | LTV2 Series Ventilators | Vyaire Medical, Inc. | 2021 | 0 | — |
| +4 | K191728 | ULTepap Expiratory Positive Airway Pressure (EPAP) Device | Bryggs Medical, LLC | 2020 | 0 | — |
| +4 | K180619 | Bongo | Innomed Healthscience, Inc. | 2018 | 1 | — |
| +4 | K123149 | Servo-I Ventilator System | Maquet Critical Care AB | 2014 | 9 | 2 |
| +4 | K132003 | Winx Sleep Therapy System | Apnicure, Inc. | 2014 | 0 | — |
| +4 | K130538 | Winx Sleep Therapy System | Apnicure, Inc. | 2013 | 2 | — |
| +4 | K122130 | Winx Sleep Therapy System | Apnicure, Inc. | 2012 | 3 | — |
| +4 | K103578 | Philips NM3 Respiratory Monitor with Ventassist | Respironics Novametrix, LLC | 2011 | 4 | — |
| +4 | K102775 | Hamilton-C2 | Hamilton Medical AG | 2011 | 14 | — |
| +4 | K093886 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010 | 21 | — |
| +4 | K100941 | Infinity Mcable - Mainstream CO2 | Draeger Medical AG & Co. KG | 2010 | 1 | — |
| +4 | K093632 | Infinity Acute Care System Workstation Neonatal Care | Drager Medical AG & Co. Kgaa | 2010 | 10 | Class I |
| +4 | K072926 | Helontix Vent | Linde Gas Therapeutics | 2008 | 0 | — |
| +4 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | 37 | — |
| +4 | K081521 | Modification to Hamilton-G5 | Hamilton Medical AG | 2008 | 16 | Class I |
| +4 | K080181 | Modification to Galileo Gold | Hamilton Medical AG | 2008 | 21 | — |
| +4 | K072412 | Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models… | Drager Medical AG & Co. Kgaa | 2008 | 23 | — |
| +4 | K072590 | Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System and… | Event Medical, Inc. | 2008 | 2 | — |
| +4 | K070513 | Hamilton-G5 | Hamilton Medical AG | 2007 | 26 | 1 |
| +4 | K071194 | Raphael Color Asv Ventilator | Hamilton Medical AG | 2007 | 0 | — |
| +4 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | 61 | — |
| +4 | K061094 | Newport E500 Wave Ventilator | Newport Medical Instruments, Inc. | 2006 | 2 | — |
| +4 | K053388 | Model 840 Ventilator with Proportional Assist Ventilation Plus Software Option | Puritan Bennett Corp. | 2006 | 6 | Class I |
| +5 | K222207 | Babylog VN800, Babylog VN600 | Draegerwerk AG & CO Kgaa | 2023 | 0 | — |
| +5 | K221118 | CO2 Mainstream Sensor | Draegerwerk AG & CO Kgaa | 2023 | 0 | — |
| +5 | K222897 | Enlight 2100 | Timpel S.A. | 2023 | 2 | — |
| +5 | K193460 | The iNAP One Sleep Therapy System | Somnice, Inc. | 2020 | 1 | — |
| +5 | K192584 | BEACON Caresystem Model 00002144 | Mermaid Care A/S | 2019 | 0 | — |
| +5 | K153688 | Edi Catheter ENFit | Maquet Critical Care AB | 2017 | 1 | 1 |
| +5 | K151814 | SERVO-U Ventilator System, SERVO-n Ventilator System | Maquet Critical Care AB | 2015 | 4 | — |
| +5 | K142679 | Carescape R860 | Datex-Ohmeda, Inc. | 2015 | 1 | Class I |
| +5 | K130178 | Inspiration Ventilator System 5I/7I | eVent Medical, Ltd. | 2013 | 0 | Class I |
| +5 | K113743 | Evolution 3E Ventilator | Event Medical, Inc. | 2012 | 0 | — |
| +5 | K121225 | Hamilton-C2 | Hamilton Medical AG | 2012 | 8 | Class I |
| +5 | K112006 | Hamilton-TC1 | Hamilton Medical AG | 2012 | 13 | — |
| +5 | K112722 | GE Datex-Ohmeda Avance | Datex-Ohmeda, Inc. | 2011 | 13 | Class I |
| +5 | K103803 | Hamilton-G5 | Hamilton Medical AG | 2011 | 14 | Class I |
| +5 | K111116 | Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000 | Datex-Ohmeda | 2011 | 3 | Class I |
| +5 | K110213 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2011 | 9 | Class I |
| +5 | K101803 | Newport E360 Ventilator | Newport Medical Instruments, Inc. | 2010 | 1 | — |
| +5 | K090468 | Hamilton-C2 | Hamilton Medical AG | 2009 | 0 | — |
| +5 | K083693 | PB 840 Ventilator System with Leak Compensation Option, Model 840 | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2009 | 6 | — |
| +5 | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 | Maquet Critical Care AB | 2008 | 28 | — |
| +5 | K073694 | Ivent 2001 Mri Conditional | Versamed Medical Systems, Inc. | 2008 | 6 | — |
| +6 | K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi… | Maquet Critical Care AB | 2026 | 0 | — |
| +6 | K250464 | Enlight 2100 (TPL-E2103-0) | Timpel S.A. | 2025 | 0 | — |
| +6 | K243765 | LuMon (TM) System | Sentec AG | 2025 | 0 | — |
| +6 | K220907 | The iNAP One Sleep Therapy System | Somnics, Inc. | 2023 | 0 | — |
| +6 | K210384 | Carescape R860 | Datex-Ohmeda, Inc. | 2021 | 0 | — |
| +6 | K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | Maquet Critical Care AB | 2019 | 3 | — |
| +6 | K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire… | Datex-Ohmeda, Inc. | 2017 | 0 | Class I |
| +6 | K140939 | Hamilton-T1,Hamilton-C1 | Hamilton Medical AG | 2015 | 2 | 1 |
| +6 | K140575 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2015 | 0 | — |
| +6 | K142552 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 5 | — |
| +6 | K132530 | GE Datex-Ohmeda Aisys CS2 (Aisys CS^2) | Datex-Ohmeda, Inc. | 2013 | 2 | 3 |
| +6 | K131774 | Hamilton-G5 | Hamilton Medical AG | 2013 | 10 | Class I |
| +6 | K122063 | Intellisave AX700 Anesthesia System | Philips Anesthesia Care | 2013 | 0 | — |
| +6 | K123125 | GE Datex-Ohmeda Avance CS2 | Datex-Ohmeda, Inc. | 2013 | 11 | Class I |
| +6 | K123637 | Hamilton-C3 | Hamilton Medical AG | 2012 | 4 | — |
| +6 | K121891 | Newport Aura Ventilator | Newport Medical Instruments, Inc. | 2012 | 0 | — |
| +6 | K120574 | Hamilton-C1 | Hamilton Medical AG | 2012 | 3 | — |
| +6 | K120670 | Hamilton-T1 | Hamilton Medical AG | 2012 | 11 | Class I |
| +6 | K111146 | Newport HT70 Ventilator | Newport Medical Instruments, Inc. | 2011 | 1 | Class I |
| +6 | K103211 | Avea Ventilator | Care Fusion | 2011 | 5 | Class I |
| +6 | K090888 | Newport HT70 Family of Ventilators | Newport Medical Instruments, Inc. | 2009 | 2 | Class I |
| +6 | K083688 | Pulmonetic Systems LTV 1200 MR Conditional Ventilator | Pulmonetic Systems, Inc. | 2009 | 2 | 1 |
| +7 | K243767 | SV600, SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025 | 0 | — |
| +7 | K240807 | VM-2000 | Ventis Medical, Inc. | 2024 | 0 | — |
| +7 | K201874 | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator… | Maquet Critical Care AB | 2021 | 0 | Class I |
| +7 | K202970 | Ventway Sparrow | Inovytech Medical Solutions, Ltd. | 2021 | 0 | — |
| +7 | K192604 | Servo-air 4.0 Ventilator System | Maquet Critica Care AB | 2020 | 0 | Class I |
| +7 | K181216 | Hamilton-T1, Hamilton-C1 | Hamilton Medical AG | 2019 | 0 | Class I |
| +7 | K180295 | Hamilton-G5 | Hamiton Medical AG | 2019 | 2 | — |
| +7 | K170872 | Aisys CS2 | Datex-Ohmeda, Inc. | 2017 | 0 | 4 |
| +7 | K162832 | 731 Series Ventilators | ZOLL Medical Corporation | 2017 | 1 | Class I |
| +7 | K161450 | Hamilton-C3 | Hamilton Medical AG | 2017 | 3 | 2 |
| +7 | K153046 | Hamilton-MR1 | Hamilton Medical AG | 2016 | 0 | Class I |
| +7 | K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 4 | 3 |
| +7 | K131790 | A9800 Anesthesia Workstation | Oricare, Inc. | 2014 | 0 | — |
| +7 | K131252 | Puritan Bennett 980 Series Ventilator System | Covidien | 2014 | 2 | Class I |