Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OBJ · Predicate Candidate Screening
79 FDA 510(k) clearances under this product code; the 50 most recent screened below.
69 daysmedian FDA review time
211 days90th percentile
79clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261849 | VERAFEYE Imaging Catheter (VF-VIC-002) | Luma Vision Limited | 2026-07-24 | 51 | 0 |
| K252945 | Novasight Hybrid System | Conavi Medical, Inc. | 2026-04-17 | 214 | 0 |
| K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross | Boston Scientific | 2026-04-08 | 26 | 0 |
| K253399 | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .01 | Volcano Corporation (Dba Philips Image Guided Therapy Device | 2025-10-28 | 28 | 0 |
| K250955 | XC11 ICE System, USA | Yorlabs, Inc. | 2025-10-22 | 205 | 0 |
| K250913 | TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System | Jiangsu Tingsn Technology Co., Ltd. | 2025-07-19 | 114 | 0 |
| K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE C | ABBOTT MEDICAL | 2025-05-23 | 35 | 0 |
| K251231 | ViewFlex™ X ICE Catheter, Sensor Enabled™ | ABBOTT MEDICAL | 2025-05-20 | 28 | 0 |
| K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); | Philips Image Guided Therapy Corporation | 2025-05-09 | 28 | 0 |
| K242893 | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging | Luma Vision Limited | 2025-03-24 | 182 | 0 |
| K241540 | NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Cath | Biosense Webster, Inc. | 2024-06-28 | 28 | 0 |
| K240050 | SOUNDSTAR™ CRYSTAL Ultrasound Catheter | Biosense Webster, Inc. | 2024-06-12 | 156 | 0 |
| K233948 | Provisio™ SLT IVUS™ System | Provisio Medical, Inc. | 2024-04-23 | 131 | 0 |
| K233270 | AcuNav Crystal Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2023-10-28 | 29 | 0 |
| K230453 | OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD C | Boston Scientific Corporation | 2023-05-18 | 86 | 0 |
| K223766 | NUVISION™ NAV Ultrasound Catheter | Biosense Webster, Inc. | 2023-02-16 | 63 | 0 |
| K223077 | ViewFlex Xtra ICE Catheter | Irvine Biomedical, A St. Jude Medical Company | 2022-12-07 | 68 | 0 |
| K222568 | OptiCross™ 18 Peripheral Imaging Catheter | Boston Scientific Corporation | 2022-09-23 | 30 | 0 |
| K213593 | OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD | Boston Scientific Corporation | 2022-01-14 | 63 | 1 |
| K212959 | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Cath | Siemens Medical Solutions USA, Inc. | 2021-10-15 | 29 | 0 |
| K201775 | NuVision ICE Catheter | Nuvera Medical, Inc. | 2021-03-05 | 249 | 0 |
| K203726 | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Cath | Siemens Medical Solutions USA, Inc. | 2021-01-19 | 29 | 0 |
| K200812 | VeriSight Intracardiac Echocardiography (ICE) Catheter, Veri | Philips Image Guided Therapy Corporation | 2020-09-02 | 159 | 0 |
| K200195 | NES Reprocessed Visions PV .014P RX Digital IVUS Catheter | Northeast Scientific, Inc. | 2020-06-22 | 147 | 0 |
| K200410 | Reconnaissance PV .018 OTW Digital IVUS Catheter | Philips Image Guided Therapy Corporation | 2020-05-22 | 93 | 0 |
| K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound Cath | Acist Medical Systems, Inc. | 2020-03-20 | 123 | 1 |
| K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi Sy | Acist Medical Systems, Inc. | 2019-06-27 | 57 | 0 |
| K172258 | Novasight Hybrid System | Conavi Medical, Inc. | 2018-04-27 | 275 | 1 |
| K173820 | OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU) | Boston Scientific Corporation | 2018-01-17 | 30 | 0 |
| K173618 | ACUSON AcuNav Volume Intracardiac Echocardiography Catheter | Siemens Medical Solutions USA, Inc. | 2017-12-19 | 27 | 0 |
| K173284 | OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); | Boston Scientific Corporation | 2017-11-16 | 31 | 0 |
| K173063 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi Sy | Acist Medical Systems, Inc. | 2017-10-23 | 24 | 0 |
| K170992 | AcuNav V 10F Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2017-06-15 | 73 | 0 |
| K170263 | AcuNav Diagnostic Ultrasound Catheter 8F,10F | Siemens Medical Solutions USA, Inc. | 2017-06-15 | 139 | 0 |
| K163478 | AcuNav Volume ICE Catheter | Siemens Medical Solutions USA, Inc. | 2017-02-09 | 59 | 0 |
| K160583 | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS | Volcano Corporation | 2016-10-26 | 239 | 2 |
| K160514 | OptiCross 18, 30 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | 2016-06-22 | 119 | 0 |
| K161125 | OptiCross X, 40 MHz Coronary Imaging Catheter | Boston Scientific Corporation | 2016-05-19 | 28 | 0 |
| K153617 | OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distributi | Boston Scientific Corporation | 2016-02-25 | 69 | 0 |
| K153094 | Visions PV .035 Digital IVUS Catheter | Volcano Corporation | 2015-12-31 | 66 | 0 |
| K152829 | Visions PV.014P RX Digital IVUS Catheter | Volcano Corporation | 2015-11-19 | 51 | 1 |
| K150442 | Volcano Visions PV .018 Digital IVUS Catheter | Volcano Corporation | 2015-09-04 | 196 | 1 |
| K143701 | EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CA | Volcano Corporation | 2015-08-26 | 245 | 0 |
| K141618 | ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VP | Arrow International, Inc (Subsidiary of Teleflex I | 2014-07-08 | 21 | 0 |
| K133853 | VIEWFLEX XTRA ICE CATHETER | Irvine Biomedical, Inc., A St. Jude Medical Company | 2014-05-19 | 151 | 0 |
| K140318 | SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTR | Biosense Webster | 2014-03-12 | 30 | 1 |
| K132133 | CG+ ARROW JACC POWERED BY ARROW VPS STYLET | Arrow International (Subsidiary of Teleflex Inc.) | 2013-09-26 | 77 | 2 |
| K123621 | OPTICROSS 40 MHZ CORONARY IMAGING CATHETER | Boston Scientific Corp | 2013-04-15 | 143 | 1 |
| K123813 | VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE | Vasonova, Inc. | 2013-01-18 | 38 | 1 |
| K122878 | HD-IVUS ULTRASOUND IMAGING SYSTEM | Silicon Vally Medical Instruments, Inc. | 2013-01-11 | 114 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda