Devices descending from K010874
160 later devices reach 6F Mach 1, Model 34356-XXX through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K061601 | Asahi Precious Guide Catheter | Asahi Intecc Co., Ltd. | 2006 | 109 | — |
| +1 | K033441 | Boston Scientific 6F Runway Guide Catheter | Boston Scientific Corp | 2003 | 26 | 2 |
| +1 | K020028 | 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX | Boston Scientific | 2002 | 132 | 11 |
| +2 | K093268 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | 105 | 2 |
| +2 | K091188 | Asahi Zenyteex Guiding Catheter | Asahi Intecc Co., Ltd. | 2010 | 1 | — |
| +2 | K072316 | Precious Plus Guide Catheter | Asahi Intecc Co., Ltd. | 2007 | 0 | — |
| +2 | K071226 | 8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043 | Spectranetics Corp. | 2007 | 21 | 2 |
| +2 | K041151 | Kerberos Occluding Guide Catheter and Accessories | Kerberos Proximal Solutions, Inc. | 2004 | 25 | — |
| +3 | K151681 | IntelliVue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2015 | 32 | 8 |
| +3 | K150975 | Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2… | Philips Medizin Systeme Boeblingen GmbH | 2015 | 34 | 1 |
| +3 | K150512 | STAR 90 | Skanray Technologies Pvt, Ltd. | 2015 | 1 | — |
| +3 | K132556 | Sheathless Eaucath Coronary Guide Catheter | Asahi Intecc Co., Ltd. | 2013 | 0 | — |
| +3 | K131872 | Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2013 | 37 | 5 |
| +3 | K131829 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2013 | 0 | — |
| +3 | K130849 | Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2013 | 37 | 8 |
| +3 | K122439 | Intellivue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2012 | 41 | 4 |
| +3 | K120366 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2012 | 46 | — |
| +3 | K113657 | Intellivue Patient Monitor | Philips Medizin Systeme Boblingen GmbH | 2012 | 81 | — |
| +3 | K113441 | Physiological Monitor, Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2012 | 78 | 1 |
| +3 | K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 36 | — |
| +3 | K110622 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 90 | 2 |
| +3 | K102562 | Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60… | Philips Medizin Systeme Boblingen GmbH | 2010 | 103 | — |
| +3 | K091299 | Spectranetics Turbo-Tandem System | Spectranetics Corp. | 2009 | 20 | — |
| +3 | K080987 | Bridgepoint Medical Stingray Device and Accessories | Bridgepoint Medical | 2009 | 24 | 1 |
| +4 | K210906 | IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot… | Philips Medizin Systeme Boeblingen GmbH | 2021 | 6 | 2 |
| +4 | K172147 | STAR 65 | Skanray Technologies Pvt, Ltd. | 2018 | 0 | — |
| +4 | K172904 | IntelliVue Capnography Extension, IntelliVue Microstream Extension | Philips Medizin Systeme Boeblingen GmbH | 2017 | 7 | — |
| +4 | K161517 | Mortara Surveyor Patient Monitor | Mortara Instrument, Inc. | 2017 | 1 | — |
| +4 | K162675 | Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter | Masimo Corporation | 2016 | 1 | — |
| +4 | K153156 | eCareManager 4.0.1 | Visicu, Inc. | 2016 | 3 | — |
| +4 | K161531 | IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2… | Philips Medizin Systeme Boeblingen GmbH | 2016 | 31 | 1 |
| +4 | K152552 | Patient Monitor | Edan Instruments, Inc. | 2016 | 2 | 1 |
| +4 | K133973 | Tempus Pro with Enhanced Features | Remote Diagnostic Technologies, Ltd. | 2014 | 3 | — |
| +4 | K140775 | Turbo-Elite Atherectomy Catheters, Turbo Tandem System | Spectranetics Corporation | 2014 | 17 | 3 |
| +4 | K141015 | Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2014 | 36 | 1 |
| +4 | K132075 | Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M) | Mindray North America | 2014 | 10 | — |
| +4 | K131913 | Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T… | Philips Medizin Systeme Boeblingen GmbH | 2013 | 0 | 1 |
| +4 | K122223 | New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment… | Philips Medizin Systeme Boeblingen GmbH | 2013 | 35 | — |
| +4 | K121763 | Multicross Support Catheter | Roxwood Medical, Inc. | 2012 | 8 | — |
| +4 | K110474 | Philips Intellivue TCG10 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 84 | 1 |
| +4 | K111963 | Bridgepoint Medical Mantaray (TM) Catheter | Bridgepoint Medical | 2011 | 7 | — |
| +4 | K102725 | Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000… | Bridge Medical, Inc. | 2011 | 11 | 1 |
| +4 | K101591 | Stingray Orienting Balloon Catheter | Bridgepoint Medical | 2010 | 14 | 1 |
| +4 | K094036 | Turbo-Tandem System Model 472-110 | Spectranetics Corp. | 2010 | 19 | — |
| +5 | K232389 | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue | Masimo Corporation | 2023 | 0 | — |
| +5 | K223681 | Respiree Cardio-Respiratory Monitor | Respiree Pte, Ltd. | 2023 | 1 | — |
| +5 | K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) | Philips Medizin Systeme Böblingen GmbH | 2023 | 3 | — |
| +5 | K221704 | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion… | Edwards Lifesciences, LLC | 2022 | 6 | — |
| +5 | K220111 | RespiraSense | Pmd Solutions | 2022 | 1 | — |
| +5 | K220530 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | 2022 | 1 | — |
| +5 | K201941 | Monitor B125, Monitor B105 | Ge Medical Systems Information Technologies, Inc. | 2020 | 3 | — |
| +5 | K192137 | IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 | Philips Medizin Systeme Boeblingen GmbH | 2020 | 0 | — |
| +5 | K193322 | NovaCross CTO Microcatheter | Nitiloop, Ltd. | 2020 | 0 | — |
| +5 | K182979 | IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2019 | 5 | — |
| +5 | K182637 | Philips IntelliVue XDS Software | Philips Medizin Systeme Boeblingen GmbH | 2019 | 0 | — |
| +5 | K181831 | IntelliVue Multi-Measurement Module MMX | Philips Medizin Systeme Boeblingen GmbH | 2018 | 0 | — |
| +5 | K181642 | B-Laser Atherectomy System | Eximo Medical, Ltd. | 2018 | 8 | — |
| +5 | K173765 | Surveyor Patient Monitor | Mortara Instrument, Inc. | 2018 | 0 | 2 |
| +5 | K181314 | IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue… | Philips Medizin Systeme Boeblingen GmbH | 2018 | 6 | — |
| +5 | K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models… | Edan Instruments, Inc. | 2018 | 1 | 2 |
| +5 | K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic… | Philips Medizin Systeme Boeblingen GmbH | 2017 | 8 | 4 |
| +5 | K170876 | Passport Series Patient Monitors (Passport 12m, Passport 17m) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017 | 3 | — |
| +5 | K171322 | eCareManager 4.1 | Visicu, Inc. | 2017 | 2 | — |
| +5 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | 2 | — |
| +5 | K170059 | Spectranetics Turbo-Elite Laser Atherectomy Catheters | Spectranetics, Inc. | 2017 | 2 | 3 |
| +5 | K152957 | MultiCross Catheter | Roxwood Medical, Inc. | 2016 | 0 | — |
| +5 | K153448 | Passport Series Patient Monitors (Including Passport 8, Passport 12) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 0 | 2 |
| +5 | K152401 | Stingray LP Catheter | Boston Scientific Corporation | 2015 | 1 | — |
| +5 | K152181 | Turbo-Power Laser Atherectomy Catheter | Spectranetics, Inc. | 2015 | 4 | 1 |
| +5 | K151736 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | 2015 | 24 | — |
| +5 | K143608 | NovaCross Microcatheter | Nitiloop, Ltd. | 2015 | 2 | — |
| +5 | K143195 | Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2014 | 9 | 1 |
| +5 | K140910 | Centercross Catheter | Roxwood Medical, Inc. | 2014 | 3 | — |
| +5 | K134031 | Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation… | Boston Scientific Corporation | 2014 | 0 | — |
| +5 | K132320 | Intellivue CL Respiration Pod | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2014 | 20 | — |
| +5 | K122795 | Stingray Guidewires | Bridgepoint Medical | 2012 | 0 | 1 |
| +5 | K120533 | Bigboss Catheters Mantatay Catheter Mantaray Guidewires | Bridgepoint Medical | 2012 | 5 | — |
| +5 | K120129 | Mantaray Catheter | Bridgepoint Medical | 2012 | 6 | — |
| +5 | K112032 | 8FR Turbo - Tandem System | Spectranetics Corp. | 2011 | 0 | — |
| +6 | K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN… | Senzime AB | 2026 | 0 | — |
| +6 | K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. | 2025 | 0 | — |
| +6 | K250934 | Respiree Cardio- Respiratory Monitor System | Respiree Pte, Ltd. | 2025 | 0 | — |
| +6 | K233953 | Makani Science™ Respiration Monitoring System | Makani Science, Inc. | 2025 | 0 | — |
| +6 | K250385 | Turbo-Elite Laser Atherectomy Catheter | Spectranetics | 2025 | 0 | — |
| +6 | K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)… | Philips Medizin Systeme Boeblingen GmbH | 2023 | 2 | — |
| +6 | K230604 | IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) | Philips Medizin Systeme Boeblingen GmbH | 2023 | 1 | — |
| +6 | K232294 | HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart… | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +6 | K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)… | Philips Medizin Systeme Boeblingen GmbH | 2023 | 2 | — |
| +6 | K231176 | Stingray LP Catheter | Boston Scientific | 2023 | 0 | — |
| +6 | K221163 | Tunnel Crossing Catheter | Tractus Vascular, LLC | 2023 | 0 | — |
| +6 | K220171 | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter | Northeast Scientific, Inc. | 2022 | 0 | 1 |
| +6 | K211046 | eCareManager 4.5 | Visicu, Inc. | 2022 | 0 | — |
| +6 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022 | 2 | 6 |
| +6 | K212047 | Pantheris System | Avinger, Inc. | 2021 | 0 | — |
| +6 | K210160 | AlertWatch:AC | Alertwatch, Inc. | 2021 | 0 | — |
| +6 | K202835 | Auryon Atherectomy System | Eximo Medical, Ltd. | 2020 | 6 | — |
| +6 | K193596 | Wingman 14, Wingman 14C, Wingman 18, Wingman 35 | Reflow Medical | 2020 | 1 | — |
| +6 | K191106 | C50 and C80 Multi-parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2019 | 1 | — |
| +6 | K190011 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019 | 0 | 2 |
| +6 | K183357 | XableCath Crossing Catheter | Xablecath, Inc. | 2019 | 0 | — |