Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DWF — Predicate Candidate Screening
401 FDA 510(k) clearances under this product code; the 50 most recent screened below.
83 daysmedian FDA review time
231 days90th percentile
401clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260195 | Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae | Medtronic, Inc. | 2026-04-23 | 91 | 2 |
| K250937 | Venous Return Cannulae | LivaNova USA, Inc. | 2026-03-11 | 348 | 0 |
| K260043 | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmon | Smart Reactors | 2026-02-23 | 47 | 0 |
| K253203 | Retrograde Coronary Sinus Perfusion Cannulae | Medtronic, Inc. | 2026-02-19 | 146 | 0 |
| K253671 | Dual Stage Venous Cannulae | Sorin Group Italia S.R.L. | 2026-01-30 | 70 | 0 |
| K253998 | Clearview Intracoronary Shunts | Medtronic, Inc. | 2026-01-20 | 39 | 0 |
| K253106 | AngioVac Cannula | AngioDynamics, Inc. | 2025-10-24 | 30 | 0 |
| K250283 | RAP Femoral Venous Cannulae | LivaNova USA, Inc. | 2025-07-10 | 160 | 0 |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | Sorin Group Italia S.R.L. | 2025-06-27 | 119 | 0 |
| K251258 | MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cann | Medtronic, Inc. | 2025-06-20 | 58 | 0 |
| K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) | Spectrum Medical S.R.L. | 2024-05-31 | 28 | 0 |
| K240193 | R501 - R502 aortic root cannulae with and without vent line | Sorin Group Italia S.R.L. | 2024-02-22 | 29 | 0 |
| K233895 | EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, | Edwards Lifesciences | 2024-02-05 | 56 | 0 |
| K231206 | DLP Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | 2023-12-07 | 224 | 0 |
| K230960 | DLP™ Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | 2023-05-04 | 29 | 0 |
| K221353 | Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion | Qura S.R.L | 2022-08-18 | 100 | 0 |
| K213540 | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia S | Qura S.R.L | 2022-05-20 | 193 | 0 |
| K203067 | Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusio | Qura S.R.L | 2021-11-08 | 395 | 0 |
| K212386 | AngioVac F18 85 | AngioDynamics, Inc. | 2021-09-30 | 59 | 0 |
| K201100 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | 2021-07-15 | 447 | 0 |
| K203057 | Quantum Perfusion Arterial Cannula Graft | Qura S.R.L | 2021-06-30 | 265 | 0 |
| K200289 | Michler-Kapp Cardiovascular Vent Catheter | Kapp Surgical Instrument, Inc. | 2021-01-28 | 358 | 0 |
| K200612 | R501 aortic root cannula without vent line, R502 aortic root | Sorin Group Italia S.R.L. | 2020-11-17 | 253 | 0 |
| K200499 | QuickDraw Venous Cannula | Edwards Lifesciences, LLC | 2020-03-29 | 30 | 0 |
| K200358 | Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Ve | Edwards Lifesciences, LLC | 2020-03-13 | 29 | 0 |
| K190594 | AngioVac C20, AngioVac C180 | AngioDynamics, Inc. | 2019-07-05 | 120 | 0 |
| K182302 | CardioGard Emboli Protection Cannula | Cardiogard Medical, Ltd. | 2019-05-17 | 266 | 0 |
| K190557 | Bio-Medicus Insertion Kit | Medtronic, Inc. | 2019-04-03 | 29 | 0 |
| K180979 | PureFlex Arterial Cannulae | Sorin Group Italia S.R.L. | 2018-11-16 | 217 | 0 |
| K182586 | DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent L | Medtronic, Inc. | 2018-10-19 | 29 | 2 |
| K181150 | ProtekDuo Mini Veno-Venous Cannula Set | Cardiacassist, Inc. | 2018-05-25 | 24 | 0 |
| K180453 | Bio-Medicus Adult Cannulae and Introducer | Medtronic, Inc. | 2018-03-22 | 30 | 0 |
| K180456 | Bio-Medicus Adult Cannulae Kit | Medtronic, Inc. | 2018-03-22 | 30 | 1 |
| K171979 | Tubing Pack | Medtronic, Inc. | 2017-10-27 | 119 | 0 |
| K170488 | Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventri | Surge Cardiovascular | 2017-08-10 | 174 | 0 |
| K162215 | Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae | Sorin Group Italia S.R.L. | 2017-06-16 | 312 | 0 |
| K171308 | Tubing Pack | Medtronic, Inc. | 2017-06-02 | 30 | 1 |
| K162500 | Ostial Sprit Cannulae | Spyder Medical | 2017-01-12 | 127 | 0 |
| K162214 | Protek Solo 24 Fr Venous Cannula Set | Cardiacassist, Inc. | 2016-11-30 | 114 | 0 |
| K160257 | PROTEK Duo 31 Fr. Veno-Venous Cannula Set | Cardiacassist, Inc. | 2016-03-04 | 32 | 0 |
| K153598 | Medtronic Bio-Medicus Adult Cannula Kit | Medtronic, Inc. | 2016-01-15 | 30 | 1 |
| K152190 | Thoratec CentriMag Drainage (Venous) Cannula Kit | Thoratec Corporation | 2015-09-18 | 44 | 0 |
| K152161 | Thoratec CentriMag Return (Arterial) Cannula Kit | Thoratec Corporation | 2015-09-18 | 46 | 0 |
| K151523 | Uncoated Tubing and Connector Components | Medtronic, Inc. | 2015-07-16 | 41 | 0 |
| K150536 | Terumo Circuit Tubing | Terumo Cardiovascular Systems Corporation | 2015-05-05 | 63 | 0 |
| K150567 | MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT | Medtronic, Inc. | 2015-04-09 | 34 | 0 |
| K143083 | Bio-Medicus Pediatric Cannula and Introducers | Medtronic, Inc. | 2015-03-25 | 149 | 0 |
| K150422 | EOPA 3D Arterial Cannula | Medtronic, Inc. | 2015-03-20 | 29 | 0 |
| K141465 | CARDIOGARD EMBOLI PROTECTION CANNULA | Cardiogard Medical, Ltd. | 2015-01-09 | 220 | 0 |
| K143107 | DLP Vein Graft Cannula | Medtronic, Inc. | 2015-01-07 | 70 | 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