Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 50
- Latest Decision
- 2026-10-02
Clearances · page 1 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K260490 | Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14) | Shenzhen Ninenovo Technology Limited | DQA | Class II | 2026-10-02 |
| K253422 | OAB Delivery Catheter | Cognition Medical Corp. | QJP | Class II | 2026-10-02 |
| K263016 | Intra-Operative Positioning System (IOPS) and IOPS Visionary System | Centerline Biomedical | DQK | Class II | 2026-10-01 |
| K260470 | Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206) | Shenzhen Brav Electronic Technologies Co., Ltd. | DXN | Class II | 2026-10-01 |
| K263092 | Dual Stage Venous Cannulae | Sorin Group Italia S.R.L. | DWF | Class II | 2026-10-01 |
| K254302 | ECG Analysis Software (AiTiALVSD) | Medical AI Co., Ltd. | QYE | Class II | 2026-09-30 |
| K261469 | Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). | Barco N.V. | DXJ | Class II | 2026-09-30 |
| K260250 | QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) | QT Medical, Inc. | DPS | Class II | 2026-09-29 |
| K262015 | Elucid FFR-IQ (B.1) | Elucid Bioimaging, Inc. | PJA | Class II | 2026-09-29 |
| K262052 | Tri Stage Venous Cannulae | Sorin Group Italia S.R.L. | DWF | Class II | 2026-09-28 |
| K254297 | Tempus ECG-MR | Tempus AI, Inc. | SBQ | Class II | 2026-09-25 |
| K254255 | S-Patch CardioAI | Wellysis Corp. | DPS | Class II | 2026-09-25 |
| K254058 | DistaSense(TM) (v1) | Life Detection Technologies | DRT | Class II | 2026-09-25 |
| K254240 | Echo-2 | Neko Health AB | QOK | Class II | 2026-09-22 |
| K260416 | ZYLOX Hippo PTA Balloon Dilatation Catheter | Zylox Medtech Co., Ltd. | LIT | Class II | 2026-09-21 |
| K253509 | TriSalus TriNav Advance Infusion System | Trisalus Life Sciences | KRA | Class II | 2026-09-21 |
| K262817 | CrossFAST Integrated Microcatheter Advanced Delivery System | Vantis Vascular, Inc. | DQY | Class II | 2026-09-18 |
| K260008 | Deterioration Index Version 2 | Epic Systems Corporation | QNL | Class II | 2026-09-18 |
| K253419 | Triever Duo Catheter | Inari Medical, Inc. | QEW | Class II | 2026-09-18 |
| K253146 | Hyperdrive 35 Guidewire | Rapid-Medical , Ltd. | DQX | Class II | 2026-09-18 |
| K261729 | EnSite X EP System | Abbott Medical | DQK | Class II | 2026-09-17 |
| K261778 | JADE SCORE PTA Scoring Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | PNO | Class II | 2026-09-16 |
| K260220 | Route 92 Medical Full Length 046 Access System | Route 92 Medical, Inc. | QJP | Class II | 2026-09-16 |
| K254212 | NC PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | LIT | Class II | 2026-09-16 |
| K254181 | Aristotle 65 Macrowire | Scientia Vascular | MOF | Class II | 2026-09-16 |
| K261438 | HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) | Eurosets S.R.L | DTZ | Class II | 2026-09-14 |
| K261089 | Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit | Maduro Medical, Inc. | NRY | Class II | 2026-09-14 |
| K261287 | Digistat Care | Ascom Ums Srl Unipersonale | MSX | Class II | 2026-09-12 |
| K261807 | Sequential Circulator (SC-4004-DL, SC-4008-DL) | Bio Compression Systems, Inc. | JOW | Class II | 2026-09-11 |
| K261580 | ZBPro Diagnostic (Version 2.0) | Zbeats, Inc. | MLO | Class II | 2026-09-11 |
| K254051 | Extroducer Infusion Catheter System | SmartWise Sweden AB | KRA | Class II | 2026-09-11 |
| K254119 | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303) | Shenzhen Xinyan Medical Technology Co.,ltd. | MWJ | Class II | 2026-09-11 |
| K261929 | Upper Arm Blood pressure monitor (BP7155D) | OMRON Healthcare, Inc. | DXN | Class II | 2026-09-10 |
| K261696 | ACUNAV Luxera 4D ICE Catheter | Siemens Medical Solutions USA, Inc. | OBJ | Class II | 2026-09-10 |
| K254074 | TruPress | Procerus Enterprises | DRS | Class II | 2026-09-10 |
| K261715 | Emboliner Embolic Protection System (EPC-03) | Emboline, Inc. | PUM | Class II | 2026-09-08 |
| K262277 | 70 NeuGlide Catheter | Piraeus Medical, Inc. | QJP | Class II | 2026-09-04 |
| K260035 | Digital Indeflator INFLANTE | UAB Telemedicina | MAV | Class II | 2026-09-04 |
| K253529 | Peerbridge COR MDx (Cor MDx) | Peerbridge Health, Inc. | MWJ | Class II | 2026-09-04 |
| K261800 | Helo Max Thrombectomy System (HEL2090) | Endovascular Engineering | QEW | Class II | 2026-09-03 |
| K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 | Filmecc Co., Ltd. | DQX | Class II | 2026-09-03 |
| K254035 | Mayumi Thrombectomy System | MicroVention, Inc., d/b/a Terumo Neuro | QEZ | Class II | 2026-09-03 |
| K254000 | Happy Health Blood Pressure Monitor | Happy Health, Inc. | DXN | Class II | 2026-09-03 |
| K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M | GE Healthcare Finland Oy | MHX | Class II | 2026-09-01 |
| K262658 | Automatic Digital Blood Pressure monitor (LD-526) | Honsun (Nantong) Co., Ltd. | DXN | Class II | 2026-08-31 |
| K254217 | Aerloom | Evolym, LLC | JOW | Class II | 2026-08-31 |
| K262735 | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) | Medtronic, Inc. | MXD | Class II | 2026-08-28 |
| K262013 | Kiba CTO Crossing Catheter | Reflow Medical, Inc. | PDU | Class II | 2026-08-28 |
| K261176 | Zoom 4S Catheter | Imperative Care, Inc. | QJP | Class II | 2026-08-28 |
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart Display | GE Healthcare Finland Oy | MHX | Class II | 2026-08-28 |
| K260617 | Tigertriever 13 Ultra Revascularization Device | Rapid Medical Ltd. | NRY | Class II | 2026-08-28 |
| K262744 | GenesisX RMN | Stereotaxis, Inc. | DXX | Class II | 2026-08-27 |
| K260751 | 35 Helix Guidewire | Piraeus Medical, Inc. | MOF | Class II | 2026-08-27 |
| K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus) | JOYTECH Healthcare Co., Ltd. | DXN | Class II | 2026-08-26 |
| K260246 | SEISMIQ Intravascular Lithotripsy System | Bolt Medical, Inc. | PPN | Class II | 2026-08-24 |
| K262538 | Artix MT;Artix Thin-Walled Sheath | Inari Medical, Inc. | QEW | Class II | 2026-08-21 |
| K262089 | Disposable Warming Blanket | Hangzhou Tappa Medical Technology Co., Ltd. | DWJ | Class II | 2026-08-21 |
| K262005 | Affera Integrated Mapping System | Medtronic, Inc. | DQK | Class II | 2026-08-21 |
| K253699 | Tempus ECG-PH | Tempus AI, Inc. | SAT | Class II | 2026-08-21 |
| K253692 | AVVIGO+ Multi-Modality Guidance System | Boston Scientific | DQK | Class II | 2026-08-21 |
| K260579 | Infinity® Acute Care System (IACS) VG8.1 | Draeger Medical Systems, Inc. | MHX | Class II | 2026-08-20 |
| K254071 | p17 XR Microcatheter | Wallaby Medical | QJP | Class II | 2026-08-18 |
| K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) | ImpediMed Limited | DSB | Class II | 2026-08-17 |
| K260559 | NHanceIT | IMDS Operation B.V. | DQY | Class II | 2026-08-14 |
| K260438 | Vital Signs Monitor (CLEO2) | Infinium Medical, Inc. | MWI | Class II | 2026-08-14 |
| K253562 | medilogFD | Schiller AG | MWJ | Class II | 2026-08-14 |
| K262424 | Willow 12 Guidewire | Arbor Endovascular, LLC | MOF | Class II | 2026-08-14 |
| K261428 | NC Euphora Rapid Exchange Balloon Dilatation Catheter | Medtronic Ireland | LOX | Class II | 2026-08-14 |
| K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set | CERENOVUS, Inc. | NRY | Class II | 2026-08-13 |
| K260211 | Dashboard (P007000) | Hill-Rom, Inc. | MSX | Class II | 2026-08-13 |
| K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P) | Joytech Healthcare Co. , Ltd. | DXN | Class II | 2026-08-13 |
| K261061 | BP Go (BPP-855) | Wellvii, Inc. | DXN | Class II | 2026-08-13 |
| K253417 | Masimo Root Monitoring System | Masimo Corporation | MWI | Class II | 2026-08-12 |
| K262399 | Millipede System | Perfuze, Ltd. | NRY | Class II | 2026-08-12 |
| K262391 | APRO 35 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC | NRY | Class II | 2026-08-12 |
| K262392 | APRO 35 Swift Catheter | Alembic, LLC | DQY | Class II | 2026-08-12 |
| K261437 | Mistral-Air® Warming System | The Surgical Company International B.V., doing business as TSC Life | DWJ | Class II | 2026-08-07 |
| K260223 | Aristotle Mini Guidewire | Scientia Vascular, Inc. | MOF | Class II | 2026-08-06 |
| K251508 | Telemetry Monitor (iT30, iT50) | Edan Instruments, Inc. | MHX | Class II | 2026-08-06 |
| K261523 | Vertex Thrombectomy System | Jupiter Endovascular | QEW | Class II | 2026-08-04 |
| K262115 | VueJect® Ultrasound Enhancing Agent Delivery System | ACIST Medical Systems, Inc. | IZQ | Class II | 2026-08-03 |
| K252812 | UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. | KRD | Class II | 2026-07-31 |
| K261335 | VitalFlow Set with Balance Biosurface | Medtronic, Inc. | QJZ | Class II | 2026-07-31 |
| K253555 | Flexitouch® Plus Advanced Pneumatic Compression System | Tactile Medical | JOW | Class II | 2026-07-31 |
| K261494 | Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730) | Shanghai Hulu Devices Co., Ltd. | DQD | Class II | 2026-07-31 |
| K252042 | Sync AV II Temporary Pacing Catheter | Swift Sync, Inc. | LDF | Class II | 2026-07-30 |
| K253526 | NAMIC Dilator and Sheath | Medline Industries, LP | DYB | Class II | 2026-07-29 |
| K261766 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | DQY | Class II | 2026-07-29 |
| K262240 | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | DQY | Class II | 2026-07-29 |
| DEN250042 | CaRi-Heart | Caristo Diagnostics , Ltd. | SIU | Class II | 2026-07-28 |
| K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. | PPN | Class II | 2026-07-27 |
| K261759 | Euphora Rapid Exchange (RX) Balloon Dilatation Catheter | Medtronic Ireland | LOX | Class II | 2026-07-27 |
| K261105 | Powered Aventus Thrombectomy System | Inquis Medical | QEZ | Class II | 2026-07-27 |
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath Set | Merit Medical Systems, Inc. | DRE | Class II | 2026-07-27 |
| K253576 | CorVista System® with PCWP Add-On | Analytics For Life, Inc. | DQK | Class II | 2026-07-26 |
| K261367 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | MSX | Class II | 2026-07-26 |
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | MHX | Class II | 2026-07-24 |
| K261488 | OBSIDIO Conformable Embolic | Boston Scientific Corporation | KRD | Class II | 2026-07-24 |
| K262165 | FARADRIVE Steerable Sheath (M004PF21M402) | Boston Scientific Corporation | DRA | Class II | 2026-07-24 |
| K261849 | VERAFEYE Imaging Catheter (VF-VIC-002) | Luma Vision Limited | OBJ | Class II | 2026-07-24 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.