Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Cardiovascular — Predicate Candidate Screening
19,134 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
143 daysmedian FDA review time
291 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261437 | Mistral-Air® Warming System | The Surgical Company International B.V., doing business as TSC Life | 2026-08-07 | 99 | 0 |
| K260223 | Aristotle Mini Guidewire | Scientia Vascular, Inc. | 2026-08-06 | 192 | 0 |
| K251508 | Telemetry Monitor (iT30, iT50) | Edan Instruments, Inc. | 2026-08-06 | 447 | 0 |
| K261523 | Vertex™ Thrombectomy System | Jupiter Endovascular | 2026-08-04 | 89 | 0 |
| K262115 | VueJect® Ultrasound Enhancing Agent Delivery System | ACIST Medical Systems, Inc. | 2026-08-03 | 41 | 0 |
| K261494 | Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethos | Shanghai Hulu Devices Co., Ltd. | 2026-07-31 | 86 | 0 |
| K252812 | UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. | 2026-07-31 | 330 | 0 |
| K261335 | VitalFlow Set with Balance™ Biosurface | Medtronic, Inc. | 2026-07-31 | 99 | 0 |
| K253555 | Flexitouch® Plus Advanced Pneumatic Compression System | Tactile Medical | 2026-07-31 | 259 | 0 |
| K252042 | Sync AV II Temporary Pacing Catheter | Swift Sync, Inc. | 2026-07-30 | 395 | 0 |
| K261766 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2026-07-29 | 62 | 0 |
| K262240 | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | 2026-07-29 | 28 | 0 |
| K253526 | NAMIC Dilator and Sheath | Medline Industries, LP | 2026-07-29 | 258 | 0 |
| DEN250042 | CaRi-Heart | Caristo Diagnostics , Ltd. | 2026-07-28 | 327 | 0 |
| K261105 | Powered Aventus Thrombectomy System™ | Inquis Medical | 2026-07-27 | 115 | 0 |
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath Set | Merit Medical Systems, Inc. | 2026-07-27 | 97 | 0 |
| K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Sh | Shockwave Medical, Inc. | 2026-07-27 | 28 | 0 |
| K261759 | Euphora Rapid Exchange (RX) Balloon Dilatation Catheter | Medtronic Ireland | 2026-07-27 | 60 | 0 |
| K253576 | CorVista System® with PCWP Add-On | Analytics For Life, Inc. | 2026-07-26 | 251 | 0 |
| K261367 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2026-07-26 | 90 | 0 |
| K261849 | VERAFEYE Imaging Catheter (VF-VIC-002) | Luma Vision Limited | 2026-07-24 | 51 | 0 |
| K262165 | FARADRIVE™ Steerable Sheath (M004PF21M402) | Boston Scientific Corporation | 2026-07-24 | 28 | 0 |
| K261488 | OBSIDIO Conformable Embolic | Boston Scientific Corporation | 2026-07-24 | 79 | 0 |
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; | Ge Medical Systems Information Technologies, Inc. | 2026-07-24 | 298 | 0 |
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) | Microlife Corporation | 2026-07-23 | 113 | 0 |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) | Guangzhou Daxin Health Technology Co., Ltd. | 2026-07-23 | 107 | 0 |
| K261694 | CORE 300 Digital Stethoscope | Eko Health, Inc. | 2026-07-23 | 62 | 0 |
| K253840 | STEDI Scan Device | Stroke DX | 2026-07-22 | 233 | 0 |
| K262086 | PreludeSYNC™ Radial Compression Device | Merit Medical Systems, Inc. | 2026-07-22 | 30 | 0 |
| K254006 | Drivewire 35 Guidewire | Rapid Medical Ltd. | 2026-07-17 | 214 | 0 |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter) | Scientia Vascular, Inc. | 2026-07-16 | 195 | 0 |
| K262030 | Aventus Thrombectomy System | Inquis Medical | 2026-07-15 | 28 | 0 |
| K262006 | EnSite™ X EP System | Abbott Medical | 2026-07-15 | 30 | 0 |
| K253667 | Accoat Guide Wire | Sp Medical A/S | 2026-07-14 | 235 | 0 |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide Wire | Merit Medical Ireland , Ltd. | 2026-07-13 | 56 | 0 |
| K260199 | SLIM Microcatheter | Balt USA, LLC | 2026-07-13 | 172 | 0 |
| K253901 | Millipede88 Access Catheter | Perfuze, Ltd. | 2026-07-09 | 216 | 0 |
| K261569 | UbiqVue™ 2AYe Cardiac System (UX2253) | Lifesignals, Inc. | 2026-07-09 | 58 | 0 |
| K252978 | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | 2026-07-09 | 295 | 0 |
| K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | 2026-07-09 | 170 | 0 |
| K260700 | BlueDop Vascular Expert | BlueDop Medical, Ltd. | 2026-07-08 | 126 | 0 |
| K260278 | ThermAffyx(TM) Patient Safety System | Stihler Electronic GmbH | 2026-07-08 | 160 | 0 |
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture | Hartman Medical Group, LLC | 2026-07-06 | 59 | 0 |
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP C | Abbott | 2026-07-02 | 30 | 0 |
| K253463 | ILR ECG Analyzer (IM007) | Implicity, Inc. | 2026-07-02 | 267 | 0 |
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | Edan Instruments, Inc. | 2026-07-02 | 330 | 0 |
| K261889 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | 2026-07-01 | 26 | 0 |
| K261808 | ISAAC Neurovascular Navigation Catheter | Microvention Inc. d/b/a Terumo Neuro | 2026-06-30 | 29 | 0 |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. | 2026-06-30 | 88 | 0 |
| K254149 | Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, | Sterilmed, Inc. | 2026-06-29 | 189 | 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