Devices descending from K000994
104 later devices reach Bipap Duet LX BI-Level System through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K011714 | Bipap Pro BI-Level System | Respironics, Inc. | 2001 | 103 | 1 |
| +2 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | 40 | — |
| +2 | K031656 | Bipap Harmony Ventilatory Support System | Respironics, Inc. | 2003 | 52 | — |
| +2 | K021861 | Remstar Pro with C-Flex Cpap System | Respironics, Inc. | 2002 | 47 | 1 |
| +2 | K020777 | Bipap Synchrony Ventilatory Support System with BI-Flex | Respironics, Inc. | 2002 | 61 | 2 |
| +3 | K091112 | Respironics Sleepeasy Cpap System | Respironics, Inc. | 2009 | 4 | — |
| +3 | K090248 | Bipap Autosv | Respironics Inc., Sleep & Home Respiratory Group | 2009 | 0 | Class I |
| +3 | K070328 | Bipap Synchrony with Avaps | Respironics Inc., Sleep & Home Respiratory Group | 2007 | 59 | — |
| +3 | K063540 | Bipap Autosv | Respironics, Inc. | 2007 | 13 | — |
| +3 | K063533 | Bipap Synchrony | Respironics, Inc. | 2007 | 30 | — |
| +3 | K053168 | Bipap Focus | Respironics (Ireland) Limited | 2006 | 11 | 1 |
| +3 | K052110 | M-Series Pro Cpap Sytem | Respironics, Inc. | 2005 | 42 | 15 |
| +3 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | 39 | — |
| +3 | K042294 | Slumbergear (TM), Model Multiple (004, 005, 005, 007) | Suiter Enterprises, Inc. | 2004 | 1 | — |
| +3 | K031064 | Invacare Polaris EX Cpap, Model ISP3000 | Invacare Corp. | 2004 | 0 | — |
| +4 | K122769 | Remstar SE | Respironics, Inc. | 2012 | 3 | Class I |
| +4 | K100343 | Pap-Cap | Pur-Sleep, Inc. | 2010 | 0 | — |
| +4 | K090539 | Bipap Autosv Advanced | Respironics Inc., Sleep & Home Respiratory Group | 2009 | 0 | Class I |
| +4 | K092043 | Bipap Synchrony 2 | Respironics, Inc. | 2009 | 4 | — |
| +4 | K090113 | Breas Vivo 40 System | Breas Medical AB | 2009 | 23 | — |
| +4 | K083526 | Trilogy 100 Ventilator | Respironics Inc., Sleep & Home Respiratory Group | 2009 | 26 | Class I |
| +4 | K082660 | V60 Ventilator, Model V8000 | Respironics California, Inc. | 2009 | 14 | Class I |
| +4 | K071560 | Provent Nasal Dilator, Model BR2 | Ventus Medical, Inc. | 2008 | 10 | — |
| +4 | K072996 | Remstar Pro M-Series Cpap & Heated Humidifier System | Respironics, Inc. | 2007 | 4 | 1 |
| +4 | K071509 | Bipap Synchrony 2 Ventilatory Support System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | 28 | 2 |
| +4 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | 35 | — |
| +4 | K061034 | Bipap Plus M-Series BI-Level System | Respironics, Inc. | 2006 | 0 | — |
| +4 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 37 | 1 |
| +5 | K252182 | SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026 | 0 | — |
| +5 | K233643 | F&P Airvo 3 NIV (PT311US) | Fisher & Paykel Healthcare, Ltd. | 2024 | 1 | — |
| +5 | K183226 | Care Orchestrator Essence | Respironics, Inc. | 2019 | 0 | — |
| +5 | K143035 | Flight 60 Ventilator | Flight Medical Innovations, Ltd. | 2016 | 1 | — |
| +5 | K133769 | 3B Resmart Bpap 25A, BMC Resmart Bpap 25A | 3B Medical, Inc. | 2014 | 3 | — |
| +5 | K130077 | Remstar SE | Respironics, Inc. | 2013 | 2 | Class I |
| +5 | K120562 | Performax Pediatric EE Total Face Mask | Respironics, Inc. | 2012 | 0 | — |
| +5 | K120726 | Flight 60 Ventilator | Flight Medical Innovations, Ltd. | 2012 | 3 | — |
| +5 | K120285 | K Series Cpap System with Heated Humidifer | Curative Medical, Inc. | 2012 | 3 | — |
| +5 | K112754 | IVENT101 | Versamed Medical Systems, Ltd. | 2012 | 9 | — |
| +5 | K111549 | Attune Sleep Apnea System | Apnicure, Inc. | 2012 | 5 | — |
| +5 | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | 8 | Class I |
| +5 | K111610 | Trilogy Series Ventilator with Oximetry | Respironics, Inc. | 2011 | 11 | Class I |
| +5 | K102985 | V60 Ventilator with PPV and Auto-Trak+ Software Options | Respironics, Inc. | 2011 | 4 | Class I |
| +5 | K103395 | Performax Total Face Mask | Respironics, Inc. | 2011 | 0 | — |
| +5 | K103167 | Stellar 150 | Resmed Germany, Inc. | 2011 | 20 | — |
| +5 | K102404 | Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea… | Ventus Medical, Inc. | 2010 | 2 | — |
| +5 | K101130 | Bipap Synchrony 2 with AF531 Full Face Mask | Respironics, Inc. | 2010 | 1 | — |
| +5 | K093416 | Trilogy 200 Ventilator | Respironics, Inc. | 2010 | 19 | Class I |
| +5 | K092818 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2010 | 11 | Class I |
| +5 | K091319 | Remstar Auto a-Flex | Respironics Inc., Sleep & Home Respiratory Group | 2009 | 22 | Class I |
| +5 | K090243 | Remstar M-Series Auto with Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2009 | 0 | — |
| +5 | K090398 | Provent Professional Sleep Apnea Therapy | Ventus Medical, Inc. | 2009 | 3 | 1 |
| +6 | K252078 | BreathePal Bilevel (GFM50-MD2201) | Compal Electronics, Inc. | 2026 | 0 | — |
| +6 | K242931 | HFT750U | Mekics Co., Ltd. | 2025 | 0 | — |
| +6 | K223120 | Ventoux VC2; Ventoux VC3 | Flight Medical Innovations, Ltd. | 2024 | 0 | — |
| +6 | K230173 | Servo-air Lite Ventilator System | Maquet Critical Care AB | 2023 | 0 | — |
| +6 | K213521 | Nihon Kohden NKV-330 Ventilator System | Nihon Kohden Orangemed, Inc. | 2022 | 2 | — |
| +6 | K201620 | Luna® G3 BPAP 25A | 3B Medical, Inc. | 2021 | 2 | — |
| +6 | K200480 | DreamStation 2 System, DreamStation 2 Advanced System | Respironics, Inc. | 2020 | 1 | — |
| +6 | K191728 | ULTepap Expiratory Positive Airway Pressure (EPAP) Device | Bryggs Medical, LLC | 2020 | 0 | — |
| +6 | K181170 | Trilogy Evo Universal | Respironics, Inc. | 2019 | 0 | Class I |
| +6 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | 5 | Class I |
| +6 | K180619 | Bongo | Innomed Healthscience, Inc. | 2018 | 1 | — |
| +6 | K162877 | VOCSN Unified Respiratory System | Ventec Life Systems, Inc. | 2017 | 6 | Class I |
| +6 | K151120 | Simple T Pediatric Nasal Mask | Respironics, Inc. | 2016 | 0 | — |
| +6 | K150639 | AF541 EE Full Face Mask | Respironics, Inc. | 2015 | 0 | — |
| +6 | K132003 | Winx Sleep Therapy System | Apnicure, Inc. | 2014 | 0 | — |
| +6 | K133868 | Astral Ventilator | Resmed, Ltd. | 2014 | 10 | 2 |
| +6 | K130171 | Flight 60 Ventilator | Flight Medical Innovations, Ltd. | 2014 | 2 | — |
| +6 | K123144 | VIVO 50 | Ge Healthcare, Breas Medical AB | 2013 | 8 | 1 |
| +6 | K122715 | Stellar 150 | Resmed Germany, Inc. | 2013 | 0 | Class I |
| +6 | K130538 | Winx Sleep Therapy System | Apnicure, Inc. | 2013 | 2 | — |
| +6 | K123897 | K Series Cpap Systems | Curative Medical, Inc. | 2013 | 2 | — |
| +6 | K121623 | Bipap a 40 Ventilatory Support System | Respironics, Inc. | 2012 | 6 | Class I |
| +6 | K122130 | Winx Sleep Therapy System | Apnicure, Inc. | 2012 | 3 | — |
| +6 | K120639 | Performax Pediatric SE Total Face Mask | Respironics, Inc. | 2012 | 0 | — |
| +6 | K113640 | Stellar 150 | Resmed Germany, Inc. | 2012 | 1 | — |
| +6 | K113288 | Vpap ST-a | Resmed, Ltd. | 2012 | 7 | — |
| +6 | K112914 | Vpap TX | Resmed, Ltd. | 2011 | 0 | — |
| +6 | K113068 | Remstar Auto a-Flex HT | Respironics, Inc. | 2011 | 9 | Class I |
| +6 | K111378 | Oximetry Interface Kit | Philips Respironics, Inc. | 2011 | 0 | Class I |
| +6 | K102465 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2011 | 1 | Class I |
| +7 | K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | 2025 | 0 | — |
| +7 | K251770 | SleepRes PAP System | Sleepres, Inc. | 2025 | 0 | — |
| +7 | K241135 | RESPOND (R) Ventilator | Corvent Medical, Inc. | 2024 | 0 | — |
| +7 | K240807 | VM-2000 | Ventis Medical, Inc. | 2024 | 0 | — |
| +7 | K213169 | BPAP System | BMC Medical Co., Ltd. | 2022 | 0 | — |
| +7 | K212263 | Luna G3 BPAP System | 3B Medical, Inc. | 2022 | 0 | — |
| +7 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | 2 | Class I |
| +7 | K193460 | The iNAP One Sleep Therapy System | Somnice, Inc. | 2020 | 1 | — |
| +7 | K160481 | Vivo 60 | Breas Medical AB | 2016 | 7 | 2 |
| +7 | K152068 | Astral 100/150 | Resmed, Ltd. | 2016 | 1 | Class I |
| +7 | K153061 | Juno VPAP ST-A | Resmed, Ltd. | 2016 | 3 | — |
| +7 | K143677 | DeVilbiss Intellipap2/DeVilbiss BLUE | Devilbiss Healthcare, LLC | 2015 | 0 | — |
| +7 | K130828 | K Series Cpap Systems | Curative Medical, Inc. | 2014 | 0 | — |
| +7 | K131702 | K Series Cpap Systems | Curative Medical, Inc. | 2013 | 0 | — |
| +7 | K131982 | Remstar Auto a-Flex HT | Respironics, Inc. | 2013 | 5 | Class I |
| +7 | K123511 | S9 Vpap TX | Resmed, Ltd. | 2013 | 1 | — |
| +7 | K122324 | Vpap S-a | Resmed, Ltd. | 2012 | 0 | — |
| +8 | K233452 | Vivo 45 LS | Breas Medical AB | 2025 | 0 | 1 |
| +8 | K220907 | The iNAP One Sleep Therapy System | Somnics, Inc. | 2023 | 0 | — |