Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 43
- Latest Decision
- 2026-07-23
Clearances · page 2 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K251576 | Total Flow Medical Femoral Arterial (TFA) cannula | Total Flow Medical Limited | SFF | 2026-07-23 | |
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) | Microlife Corporation | DXN | Class II | 2026-07-23 |
| K261694 | CORE 300 Digital Stethoscope | Eko Health, Inc. | DQD | Class II | 2026-07-23 |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) | Guangzhou Daxin Health Technology Co., Ltd. | DXN | Class II | 2026-07-23 |
| K253840 | STEDI Scan Device | Stroke DX | QAF | Class II | 2026-07-22 |
| K262086 | PreludeSYNC Radial Compression Device | Merit Medical Systems, Inc. | DXC | Class II | 2026-07-22 |
| K254006 | Drivewire 35 Guidewire | Rapid Medical Ltd. | MOF | Class II | 2026-07-17 |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter) | Scientia Vascular, Inc. | NRY | Class II | 2026-07-16 |
| K262030 | Aventus Thrombectomy System | Inquis Medical | QEZ | Class II | 2026-07-15 |
| K262006 | EnSite X EP System | Abbott Medical | DQK | Class II | 2026-07-15 |
| K253667 | Accoat Guide Wire | Sp Medical A/S | DQX | Class II | 2026-07-14 |
| K260199 | SLIM Microcatheter | Balt USA, LLC | QJP | Class II | 2026-07-13 |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide Wire | Merit Medical Ireland , Ltd. | DQX | Class II | 2026-07-13 |
| K253901 | Millipede88 Access Catheter | Perfuze, Ltd. | QJP | Class II | 2026-07-09 |
| K261569 | UbiqVue 2AYe Cardiac System (UX2253) | Lifesignals, Inc. | DRG | Class II | 2026-07-09 |
| K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | DSH | Class II | 2026-07-09 |
| K252978 | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | DQK | Class II | 2026-07-09 |
| K260278 | ThermAffyx(TM) Patient Safety System | Stihler Electronic GmbH | DWJ | Class II | 2026-07-08 |
| K260700 | BlueDop Vascular Expert | BlueDop Medical, Ltd. | DPW | Class II | 2026-07-08 |
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) | Hartman Medical Group, LLC | DYB | Class II | 2026-07-06 |
| K253463 | ILR ECG Analyzer (IM007) | Implicity, Inc. | DQK | Class II | 2026-07-02 |
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | Edan Instruments, Inc. | DPS | Class II | 2026-07-02 |
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | Abbott | DQY | Class II | 2026-07-02 |
| K261889 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | QJP | Class II | 2026-07-01 |
| K261808 | ISAAC Neurovascular Navigation Catheter | Microvention Inc. d/b/a Terumo Neuro | QJP | Class II | 2026-06-30 |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. | DQK | Class II | 2026-06-30 |
| K254149 | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485) | Sterilmed, Inc. | OWQ | Class II | 2026-06-29 |
| K261455 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | DQO | Class II | 2026-06-26 |
| K261745 | LightningWire Transseptal Puncture System (TPS) | ElectroWire Medical | DXF | Class II | 2026-06-26 |
| K261242 | SimplGuide | Pendracare | DYB | Class II | 2026-06-25 |
| K253386 | DVT Garment | Vistar Medical Supplies Co., Ltd. | JOW | Class II | 2026-06-25 |
| K253384 | mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) | Seers Technology Co., Ltd. | MWJ | Class II | 2026-06-25 |
| K261866 | Concerto Versa Detachable Coil | Medtronic, Inc. | KRD | Class II | 2026-06-24 |
| K254287 | Medline Reusable Blood Pressure Cuff | Medline Industries, LP | DXQ | Class II | 2026-06-22 |
| K261950 | Health Line Tearaway Introducer | Health Line International Corporation | DYB | Class II | 2026-06-22 |
| K254169 | SmartSpectra Vital Signs Monitor 1.0 | Presage Security, Inc. d/b/a Presage Technologies, Inc. | QME | Class II | 2026-06-18 |
| K261707 | MEMO 4D Curve Semirigid mitral annuloplasty ring | Corcym S.r.l. | KRH | Class II | 2026-06-18 |
| K252839 | ZywieZ3 Sensor & Adhesive | Zywie, Inc. | MWJ | Class II | 2026-06-18 |
| K253126 | Wrist Blood Pressure Monitor (XW-05) | Shenzhen Ziqing Medical Equipment Co., Ltd. | DXN | Class II | 2026-06-18 |
| K261631 | Amplatzer TorqVue Exchange System | Abbott Medical | DQY | Class II | 2026-06-17 |
| K260693 | VicorderCS (VCS-SYS-1100) | 80 Beats Medical GmbH | DXN | Class II | 2026-06-16 |
| K253059 | Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) | Tournicare Pty, Ltd. | DXN | Class II | 2026-06-15 |
| K260635 | HARBOR Occlusion Device | Nuvascular, Inc. | KRD | Class II | 2026-06-12 |
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Midmark Corporation | MWI | Class II | 2026-06-12 |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. | DQK | Class II | 2026-06-12 |
| K253650 | Anura Mobile Core SDK (M1) | Nuralogix Corporation | QME | Class II | 2026-06-11 |
| K261610 | Verge Microcatheter | Instylla, Inc. | KRA | Class II | 2026-06-11 |
| K250690 | Penumbra System (Thunderbolt Aspiration Tubing) | Penumbra, Inc. | NRY | Class II | 2026-06-10 |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) | Centerline Biomedical | DQK | Class II | 2026-06-10 |
| K261549 | BOBBY Balloon Guide Catheter | MicroVention, Inc., d/b/a Terumo Neuro | QJP | Class II | 2026-06-09 |
| K260332 | EchoNext | Pathwai, Inc. | QXO | Class II | 2026-06-08 |
| K260289 | Perfect-O Ostial Positioning Catheter | Balosmark, Inc. | DQY | Class II | 2026-06-05 |
| K261492 | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | DYB | Class II | 2026-06-05 |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | Edwards Lifesciences | DXC | Class II | 2026-06-05 |
| K254209 | Radius VSM and Accessories | Masimo Corporation | MHX | Class II | 2026-06-04 |
| K253124 | Upper arm electronic blood pressure monitor (XB-01) | Shenzhen Ziqing Medical Equipment Co., Ltd. | DXN | Class II | 2026-06-03 |
| K252859 | ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. | DQK | Class II | 2026-05-29 |
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) | Philips Medizin Systeme Böblingen GmbH | DQA | Class II | 2026-05-29 |
| K252840 | M12 Telemetry System | Global Instrumentation, LLC | MHX | Class II | 2026-05-29 |
| K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N | Bioptimal International Pte. , Ltd. | DQO | Class II | 2026-05-28 |
| K253359 | Zenith Distal Access Long Sheath | Suzhou Zenith Vascular SciTech Limited | QJP | Class II | 2026-05-22 |
| K252915 | AiSteth® | Ai Health Highway India Pvt., Ltd. | DQD | Class II | 2026-05-22 |
| K254137 | InQwire Amplatz Guide Wire | Merit Medical Ireland, Ltd. | DQX | Class II | 2026-05-22 |
| K254129 | Spectrum-2 | Neko Health AB | MUD | Class II | 2026-05-22 |
| K252772 | Arc Adjustable Radial Cuff Compression Device | Tz Medical, Inc. | DXC | Class II | 2026-05-22 |
| DEN250057 | PCWP Analysis Software | Cardiosense, Inc. | SIF | Class II | 2026-05-22 |
| K260066 | PanopticAI Vital Signs (1.6.1-22) | PanopticAI Technologies Limited | QME | Class II | 2026-05-21 |
| K252707 | Zenith Aspiration Catheter; Disposable Aspiration Tubing Set | Suzhou Zenith Vascular SciTech Limited | NRY | Class II | 2026-05-20 |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | Class II | 2026-05-20 |
| K260304 | WAVE PTA Balloon Catheter | WAVE Medical AG | LIT | Class II | 2026-05-20 |
| K253570 | Blood Pressure Monitor (W06LT) | Shenzhen Jamr Technology Co., Ltd. | DXN | Class II | 2026-05-20 |
| K261286 | The Circadia C300 System (C300) | Circadia Health, Inc. | DRT | Class II | 2026-05-20 |
| K260771 | TruSelect 2.6 Microcatheter | Boston Scientific Corporation | KRA | Class II | 2026-05-15 |
| K252652 | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr | Fortis Biosolutions Company Limited | DXT | Class II | 2026-05-14 |
| K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) | Shenzhen Urion Technology Co., Ltd. | DXN | Class II | 2026-05-14 |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable | Acist Medical Systems, Inc. | DXT | Class II | 2026-05-13 |
| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804) | Acist Medical Systems, Inc. | DXT | Class II | 2026-05-13 |
| K254178 | SAYA 86 Radial Access Guide Catheter | Asahi Intecc Co., Ltd. | QJP | Class II | 2026-05-11 |
| K252655 | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT) | Shenzhen Imdk Medical Technology Co., Ltd. | DQA | Class II | 2026-05-11 |
| K254276 | Lynx Aspiration Catheter System | QApel Medical, Inc. | NRY | Class II | 2026-05-07 |
| K253152 | BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) | Biozen, LLC | DXN | Class II | 2026-05-06 |
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff | Nihon Kohden Corporation | DXQ | Class II | 2026-05-06 |
| K253855 | KardiaPSI Balloon Catheter | Intervention Tech, Inc. ; dba Corvention | OZT | Class II | 2026-05-06 |
| K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) | Philips Medizin Systeme | DQA | Class II | 2026-05-01 |
| K261074 | BIOMONITOR IV (471155) | Biotronik, Inc. | MXD | Class II | 2026-05-01 |
| K253436 | c-med0 alpha | Cosinuss GmbH | MWI | Class II | 2026-04-30 |
| K260606 | Echo Large Bore Introducer Sheath | Echo Medical, LLC | DYB | Class II | 2026-04-29 |
| K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire | Scientia Vascular, Inc. | MOF | Class II | 2026-04-29 |
| K252501 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L) | Joytech Healthcare Co. , Ltd. | DXN | Class II | 2026-04-28 |
| K260260 | Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) | Honsun (Nantong) Co., Ltd. | DXN | Class II | 2026-04-28 |
| K252445 | Fusion Bioline Vascular Graft | Maquet Cardiovascular, LLC | DSY | Class II | 2026-04-27 |
| K260599 | INDIGO® Aspiration System INDIGO Link | Penumbra, Inc. | QEW | Class II | 2026-04-24 |
| K250242 | Compression Therapy Device (LGT-2202DVT) | Guangzhou Longest Medical Technology Co., Ltd. | JOW | Class II | 2026-04-24 |
| K252810 | FloPatch FP120 | Flosonics Medical | DPW | Class II | 2026-04-24 |
| K260993 | Amplatzer TorqVue Delivery System | Abbott | DQY | Class II | 2026-04-24 |
| K250349 | Vista CMS | Shanghai Draeger Medical Instrument Co., Ltd. | MHX | Class II | 2026-04-24 |
| K261012 | OptiMap Catheter - 60mm (OPTI-CATH2-60) | Cortex, Inc. | MTD | Class II | 2026-04-23 |
| K254248 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | DYB | Class II | 2026-04-23 |
| K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae | Medtronic, Inc. | DWF | Class II | 2026-04-23 |
| K252389 | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | Smwmed, Inc. | DSH | Class II | 2026-04-23 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.