Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DQO — Predicate Candidate Screening
501 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
259 days90th percentile
501clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261455 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | 2026-06-26 | 56 | 0 |
| K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD | Bioptimal International Pte. , Ltd. | 2026-05-28 | 274 | 0 |
| K254278 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | 2026-03-25 | 85 | 0 |
| K250751 | DualView Catheter | Terumo Corporation | 2025-07-17 | 127 | 0 |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Ima | Gentuity, LLC | 2025-01-31 | 127 | 1 |
| K242420 | pNOVUS 21 Microcatheter | Phenox, Ltd. | 2024-11-12 | 89 | 0 |
| K233268 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | 2024-05-22 | 236 | 0 |
| K233975 | Zoom 6F Insert Catheters | Imperative Care, Inc. | 2024-04-02 | 109 | 0 |
| K232536 | Soldier Microcatheter | Embolx, Inc. | 2024-02-23 | 186 | 0 |
| K232573 | INFINITI™ Ambi Angiographic Catheter | Cordis US Corp | 2023-11-21 | 88 | 0 |
| K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging C | Gentuity, LLC | 2023-08-08 | 155 | 0 |
| K231293 | Drakon™ and Sequre® Microcatheters | Accurate Medical Therapeutics | 2023-06-01 | 28 | 0 |
| K230411 | Dragonfly OpStar™ Imaging Catheter | ABBOTT MEDICAL | 2023-04-14 | 58 | 0 |
| K221279 | pNOVUS 21 Microcatheter | Phenox, Ltd. | 2022-11-28 | 209 | 0 |
| K213666 | NuCath Wedge Pressure Catheter | Pfm Medical, Inc. | 2022-10-06 | 318 | 0 |
| K221470 | Langston dual lumen catheter | Vascular Solutions, LLC | 2022-06-17 | 28 | 0 |
| K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque marker | Cordis Corporation | 2022-02-17 | 153 | 0 |
| K211078 | Progreat Lambda | Terumo Clinical Supply Co., Ltd. | 2021-12-21 | 253 | 0 |
| K203487 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | 2020-12-11 | 14 | 0 |
| K202797 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | 2020-10-23 | 30 | 0 |
| K193647 | Superpipe Angiographic Catheter | Suzhou Hengrui Disheng Medical Co., Ltd. | 2020-07-29 | 212 | 0 |
| K192267 | ILUMIEN System with AptiVue Software version D.3 | ABBOTT MEDICAL | 2019-12-17 | 118 | 0 |
| K192122 | Trevo Trak 21 Microcatheter | Stryker | 2019-11-22 | 108 | 0 |
| K192019 | Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software versio | ABBOTT MEDICAL | 2019-11-08 | 102 | 1 |
| K190126 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2019-08-22 | 206 | 0 |
| K191608 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | 2019-07-16 | 29 | 0 |
| K181722 | Polyethylene Catheter | Cook Incorporated | 2019-03-22 | 266 | 0 |
| K180846 | Arterial Pressure Monitoring Set/Tray | Cook Incorporated | 2018-12-19 | 261 | 1 |
| K180792 | Arterial Pressure Monitoring Set/Tray | Cook Incorporated | 2018-11-30 | 248 | 0 |
| K180286 | Polyethylene Catheter | Cook Incorporated | 2018-10-26 | 267 | 0 |
| K180054 | Royal Flush Plus High-Flow Catheter | Cook Incorporated | 2018-10-05 | 270 | 0 |
| K181836 | 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography | Cordis, A Cardinal Health Company | 2018-08-08 | 29 | 0 |
| K173762 | AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Cathete | AngioDynamics, Inc. | 2018-07-18 | 219 | 18 |
| K172635 | High-Flo Silver Polyethylene Catheter | Cook Incorporated | 2018-04-03 | 214 | 0 |
| K180677 | Surefire Spark Infusion System | Surefire Medical, Inc. | 2018-04-03 | 19 | 0 |
| K173430 | SeQure® NF and SeQure® Microcatheters | Accurate Medical Therapeutics, Ltd. | 2018-01-26 | 85 | 0 |
| K171264 | Royal Flush Catheter | Cook Incorporated | 2018-01-25 | 269 | 0 |
| K170544 | Langston dual lumen catheter | Vascular Solutions, Inc. | 2017-11-17 | 266 | 0 |
| K173289 | Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Ti | Cook Incorporated | 2017-11-15 | 30 | 2 |
| K170223 | Progreat | Ashitaka Factory of Terumo Corporation | 2017-07-21 | 177 | 0 |
| K162448 | White Sizing Catheter, Aurous Centimeter Sizing Catheter, Ca | Cook Incorporated | 2017-05-26 | 267 | 1 |
| K171355 | Surefire Precision Infusion System | Surefire Medical, Inc. | 2017-05-17 | 8 | 0 |
| K161596 | Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters | AngioDynamics, Inc. | 2017-04-28 | 323 | 20 |
| K170406 | Plato MICROCATH 27B Microcatheter | Scientia Vascular, LLC | 2017-04-18 | 67 | 0 |
| K162789 | Foresight Intracardiac Echocardiology (ICE) System | Conavi Medical, Inc. | 2017-03-28 | 175 | 0 |
| K160660 | Medline Waste Station | Medline Industries, Inc. | 2017-01-19 | 317 | 0 |
| K163141 | NAMIC ClearaCIL Contrast Injection Lines | AngioDynamics, Inc. | 2017-01-06 | 58 | 0 |
| K161822 | Torcon NB Advantage Catheters | Cook Incorporated | 2016-10-27 | 118 | 0 |
| K161287 | DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, | Medtronic Vascular | 2016-08-19 | 102 | 1 |
| K160662 | Surefire Infusion System | Surefire Medical, Inc. | 2016-03-11 | 2 | 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