Devices descending from K021219
90 later devices reach Smartwire/Smartmap Pressure System through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K100930 | Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J | Volcano Corporation | 2010 | 14 | — |
| +1 | K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow System | Volcano Corporation | 2008 | 25 | 3 |
| +1 | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | 28 | 2 |
| +1 | K070487 | Smartwire Pressure Guide Wire, Model 66XX | Volcano Corporation | 2007 | 44 | — |
| +1 | K042996 | Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide Wire | Volcano Therapeutics, Inc. | 2004 | 29 | — |
| +1 | K041134 | Combomap Pressure and Flow System | Volcano Therapeutics, Inc. | 2004 | 85 | — |
| +2 | K192340 | OptoMonitor | Opsens, Inc. | 2019 | 7 | — |
| +2 | K172258 | Novasight Hybrid System | Conavi Medical, Inc. | 2018 | 1 | Class I |
| +2 | K161263 | OptoMonitor II | Opsens, Inc. | 2016 | 0 | — |
| +2 | K142598 | Opto Wire and OptoMonitor System | Opsens, Inc. | 2015 | 12 | — |
| +2 | K123792 | Horizon Xvu (FFR) | Mennen Medical, Ltd. | 2013 | 0 | — |
| +2 | K111395 | Primewire Prestige Plus | Volcano Corporation | 2011 | 13 | 1 |
| +2 | K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure System | Volcano Corporation | 2011 | 24 | 1 |
| +2 | K081626 | Flowpicc Console | Vasonova, Inc. | 2008 | 39 | — |
| +2 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | 40 | — |
| +3 | K252945 | Novasight Hybrid System | Conavi Medical, Inc. | 2026 | 0 | — |
| +3 | K201720 | LiPPS Analyzer, LiPPS Wire Pressure Guide Wire | Beijing Bywave Sensing Medical Technology Co., Ltd. | 2021 | 0 | — |
| +3 | K202943 | OptoMonitor 3 | Opsens, Inc. | 2020 | 5 | — |
| +3 | K193620 | OptoMonitor 3 | Opsens, Inc. | 2020 | 6 | — |
| +3 | K152991 | OptoWire Deux | Opsens | 2016 | 6 | — |
| +3 | K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System | Volcano Corporation | 2013 | 21 | 10 |
| +3 | K113486 | Volcano S5I Intravascular Ultracound Imaging and Pressure System | Volcano Corporation | 2012 | 2 | — |
| +3 | K103255 | Vascular Positioning System TM (VPS TM System) Stylet | Vasonova, Inc. | 2011 | 10 | 4 |
| +3 | K103260 | Vascular Positioning System (VPS System) Console | Vasonova, Inc. | 2011 | 1 | — |
| +3 | K093510 | Lumenvu Catheter Guidance System | Sonosite,Inc. | 2010 | 0 | — |
| +3 | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | 38 | 11 |
| +4 | K213854 | SavvyWire | Opsens, Inc. | 2022 | 4 | — |
| +4 | K191907 | OptoWire III | Opsens, Inc. | 2020 | 5 | — |
| +4 | K172397 | Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2017 | 0 | — |
| +4 | K142267 | Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2014 | 1 | — |
| +4 | K141618 | Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet Plus | Arrow International, Inc (Subsidiary of Teleflex I | 2014 | 1 | — |
| +4 | K133323 | Volcano Ifr Modality | Volcano Corporation | 2014 | 18 | — |
| +4 | K133142 | Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano Lomap Option for… | Volcano Corporation | 2013 | 0 | — |
| +4 | K132659 | Volcano Preview Forward-Looking Ivus System | Volcano Corporation | 2013 | 0 | — |
| +4 | K132133 | CG+ Arrow Jacc Powered by Arrow VPS Stylet | Arrow International (Subsidiary of Teleflex Inc.) | 2013 | 3 | Class I |
| +4 | K122826 | Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000… | Volcano Corporation | 2013 | 1 | — |
| +4 | K123813 | Vascular Positioning System (VPS) G4 Console | Vasonova, Inc. | 2013 | 0 | 1 |
| +4 | K123759 | CG+ Arrow Picc Powered by Arrow VPS Stylet | Arrow International, Inc. (Subsidiary of Teleflex | 2013 | 3 | — |
| +4 | K122545 | CG+ Arrow Picc Powered by Arrow VPS Stylet | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | 2 | Class I |
| +4 | K121941 | Arrow Picc Powered by Arrow VPS Stylet | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | 0 | 10 |
| +4 | K113808 | The Sherlock 3CG Tip Confirmation System (TCS) | C.R. Bard, Inc. | 2012 | 6 | — |
| +4 | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | 34 | — |
| +5 | K252674 | Solo Pace Fusion System (SOLOFUSE1) | Solo Pace, Inc. | 2026 | 0 | — |
| +5 | K241418 | OptoMonitor 3 | Opsens, Inc. | 2025 | 1 | — |
| +5 | K240864 | PacePro Wire | Opsens, Inc. | 2024 | 0 | — |
| +5 | K222232 | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly | Bard Access Systems, Inc. | 2022 | 0 | — |
| +5 | K183320 | Ilumien Optis, Optis Integrated, Optis Mobile | St. Jude Medical (Now Abbott Medical) | 2019 | 2 | — |
| +5 | K183099 | QUANTIEN Measurement System | St. Jude Medical (Now Abbott Medical) | 2019 | 3 | — |
| +5 | K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound… | Volcano Corporation | 2018 | 4 | — |
| +5 | K153487 | CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016 | 0 | Class I |
| +5 | K153423 | CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016 | 1 | Class I |
| +5 | K153369 | SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz | Volcano Corporation | 2015 | 2 | — |
| +5 | K150109 | Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain… | Arrow International (A Subsidiary of Teleflex, Inc.) | 2015 | 0 | — |
| +5 | K150441 | Volcano iFR Modality, iFR Scout feature | Volcano Corporation | 2015 | 9 | — |
| +5 | K143122 | Volcano iFR Harvest Software (Offline) | Volcano Corporation | 2015 | 0 | — |
| +5 | K142889 | Celerity PICC Tip Confirmation System | AngioDynamics, Inc. | 2015 | 8 | 1 |
| +5 | K141634 | Nautilus Delta | Romedex International Srl | 2015 | 4 | — |
| +5 | K140799 | Celerity Sysyem | Medcomp (Medical Components, Inc.) | 2014 | 13 | 1 |
| +5 | K140345 | The Sherlock 3CG Tip Confirmation System (TCS) | C.R. Bard, Inc. | 2014 | 2 | — |
| +5 | K130876 | CG+ Arrow Picc Powered by Arrow VPS Stylet | Arrow International, Inc. | 2013 | 2 | Class I |
| +5 | K112744 | Sapiens Tip Confirmation System | C.R. Bard, Inc. | 2011 | 7 | — |
| +6 | K251367 | OptoMonitor 3 | Opsens, Inc. | 2026 | 0 | — |
| +6 | K252238 | CoroFlow Cardiovascular System | Coroventis Research AB | 2025 | 0 | — |
| +6 | K241910 | Neonav ECG Tip Location System | Navi Medical Technologies | 2025 | 2 | — |
| +6 | K233948 | Provisio™ SLT IVUS™ System | Provisio Medical, Inc. | 2024 | 0 | — |
| +6 | K232386 | ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™… | Abbott Medical | 2023 | 0 | — |
| +6 | K220243 | Ultiri Measurement System | Abbott Medical | 2022 | 0 | — |
| +6 | K200037 | Piccolo Medical SmartPICC System | Piccolo Medical, Inc. | 2021 | 3 | — |
| +6 | K201881 | CoroFlow Cardiovascular System | Coroventis Research AB | 2020 | 1 | — |
| +6 | K192267 | ILUMIEN System with AptiVue Software version D.3 | Abbott Medical | 2019 | 0 | — |
| +6 | K190078 | IntraSight | Volcano Corporation | 2019 | 2 | — |
| +6 | K180560 | Sherlock 3CG+ T ip Confirmation System | C.R. Bard, Inc. | 2018 | 1 | — |
| +6 | K171931 | Celerity ECG Cable Accessory Pack | Medcomp (Medical Components, Inc.) | 2017 | 0 | — |
| +6 | K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2… | Volcano Corporation | 2017 | 0 | 1 |
| +6 | K170133 | FFR V2.5 | Philips Volcano | 2017 | 5 | 1 |
| +6 | K170385 | CORE M2 Vascular System | Volcano Corporation | 2017 | 1 | — |
| +6 | K161765 | CG+ Arrow JACC | Arrow International, Inc. (Subsidiary of Teleflex | 2016 | 0 | — |
| +6 | K152261 | PICC Tip Positioning Aid | Nostix, LLC | 2015 | 5 | — |
| +6 | K143238 | C3 Wave | Medcomp ( Medical Components) | 2015 | 3 | — |
| +7 | K260929 | Neonav ECG Tip Location System | Navi Medical Technologies | 2026 | 0 | — |
| +7 | K253714 | IntraSight Plus | Philips Image Guided Therapy Corporation | 2026 | 0 | 1 |
| +7 | K252792 | PM2™ System with ECGuide™ Connector | Piccolo Medical, Inc. | 2025 | 0 | — |
| +7 | K243484 | PM2+ System and SmartPICC Stylet | Piccolo Medical, Inc. | 2025 | 0 | — |
| +7 | K240486 | PM2 System and ECGuide Connector | Piccolo Medical, Inc. | 2024 | 2 | — |
| +7 | K203719 | IntraSight Mobile | Volcano Corporation | 2021 | 0 | 1 |
| +7 | K170934 | C3 Wave System | Medical Components, Inc (Dba Medcomp_ | 2017 | 2 | 1 |
| +7 | K160925 | VPS Rhythm Device with TipTracker Technology | Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) | 2016 | 4 | Class I |
| +8 | K241587 | pilot TLS | Vygon Corporation | 2025 | 0 | — |
| +8 | K220363 | VPS Rhythm DLX Device with TipTracker Technology | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2022 | 0 | — |
| +8 | K180567 | C3 Wave System | Medical Components, Inc. (dba MedComp) | 2018 | 0 | — |