Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MJN — Predicate Candidate Screening
90 FDA 510(k) clearances under this product code; the 50 most recent screened below.
108 daysmedian FDA review time
269 days90th percentile
90clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243795 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | 2025-09-05 | 269 | 0 |
| K251358 | Bridge Plus Occlusion Balloon (590-002) | Philips Image Guided Therapy Devices | 2025-06-24 | 55 | 0 |
| K221294 | preCARDIA Occlusion System | Abiomed, Inc. | 2023-06-30 | 422 | 0 |
| K214060 | LANDMARK REBOA Catheter | Zien Medical Technologies, Inc. | 2022-09-19 | 266 | 0 |
| K211610 | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | 2022-02-14 | 265 | 0 |
| K212324 | RenovoCath | Renovorx, Inc. | 2021-08-23 | 28 | 0 |
| K210602 | AortaSTAT Occlusion Device | Renalpro Medical, Inc. | 2021-07-09 | 130 | 0 |
| K210358 | Neurescue device | Neurescue Aps | 2021-05-21 | 102 | 0 |
| K201652 | COBRA-OS Kit | Front Line Medical Technologies, Inc. | 2021-02-22 | 249 | 0 |
| K203540 | Bridge Occlusion Balloon | Spectranetics, Inc. | 2020-12-23 | 20 | 0 |
| K200459 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | 2020-06-03 | 99 | 0 |
| K192786 | Gatekeeper Balloon Catheter | Arch Catheter, LLC | 2020-04-25 | 208 | 0 |
| K193440 | ER-REBOA PLUS Catheter | Prytime Medical Devices, Inc. | 2020-01-09 | 29 | 0 |
| K191606 | RenovoCath | Renovorx, Inc. | 2019-08-07 | 51 | 0 |
| K183045 | Eclipse 2L | Balt USA, LLC | 2019-04-30 | 179 | 0 |
| K183679 | Occlusion Balloon Catheter | Qxmedical, LLC | 2019-04-24 | 117 | 0 |
| K182916 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 F | Lemaitre Vascular | 2018-11-16 | 29 | 0 |
| K180904 | Sniper Infusion Catheter with Balloon Occlusion | Embolx, Inc. | 2018-06-08 | 63 | 0 |
| K172567 | GORE Molding and Occlusion Balloon Catheter | W. L. Gore and Associates, Inc. | 2018-01-31 | 159 | 0 |
| K172790 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017-11-08 | 54 | 0 |
| K170411 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017-04-04 | 53 | 0 |
| K160067 | RenovoCath | Renovorx, Inc. | 2017-03-07 | 419 | 0 |
| K160598 | REBOA Balloon Catheter | NuMED, Inc. | 2016-06-20 | 110 | 0 |
| K153530 | Bridge Occlusion Balloon | Spectranetics, Inc. | 2016-02-05 | 58 | 1 |
| K152833 | Pruitt F3-S Polyurethane Carotid Shunt | LeMaitre Vascular, Inc. | 2016-01-21 | 114 | 0 |
| K152762 | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | 2015-11-23 | 60 | 0 |
| K143454 | Pruitt F3-S Carotid Shunt | LeMaitre Vascular, Inc. | 2015-08-27 | 267 | 0 |
| K143613 | PaxWire Occlusion Balloon System | Accessclosure, Inc. | 2015-08-14 | 238 | 0 |
| K142692 | Occlusion Balloon Catheter | Embolx, Inc. | 2015-05-31 | 251 | 0 |
| K141175 | RENOVOCATH RC120 | Renovorx, Inc. | 2014-10-24 | 171 | 1 |
| K140273 | EQUALIZER OCCLUSION BALLOON CATHETER | Boston Scientific Corp | 2014-07-22 | 169 | 0 |
| K132022 | LEMAITRE 8F OCCLUSION CATHETER | LeMaitre Vascular, Inc. | 2013-11-06 | 128 | 0 |
| K132990 | OCCLUSION BALLOON CATHETER | Boston Scientific Corp | 2013-10-22 | 28 | 0 |
| K131869 | PTS-X SIZING BALLOON CATHETER | NuMED, Inc. | 2013-08-08 | 45 | 0 |
| K122576 | TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER CO | Stryker Neurovascular | 2013-01-11 | 141 | 8 |
| K121785 | SCEPTER C OCCLUSION BALLOON CATHETER | MicroVention, Inc. | 2012-08-10 | 53 | 0 |
| K113698 | SCEPTER XC OCCLUSION BALLOON CATHETER | MicroVention, Inc. | 2012-01-13 | 28 | 0 |
| K112219 | TAPAS CATHETER | Thermopeutix, Inc. | 2011-11-18 | 108 | 0 |
| K110741 | SCEPTER C OCCLUSION BALLOON CATHETER | MicroVention, Inc. | 2011-09-29 | 197 | 0 |
| K110903 | PTS-X SIZING BALLOON CATHETER | NuMED, Inc. | 2011-04-29 | 29 | 0 |
| K103780 | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCE | Micrus Endovascular Corporation | 2011-01-26 | 30 | 0 |
| K103356 | PRUITT CAROTID KIT | LeMaitre Vascular, Inc. | 2010-12-08 | 22 | 0 |
| K093847 | DUFLO CATHETER (HEPARIN COATED) | Thermopeutix, Inc. | 2010-08-25 | 252 | 0 |
| K101570 | HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS | Micro Therapeutics Dba Ev3 Neurovascular | 2010-07-13 | 39 | 0 |
| K100063 | HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION B | Ev3, Inc. | 2010-02-02 | 22 | 0 |
| K093911 | FOGARTY OCCLUSION CATHETER | Edwards Lifesciences, LLC | 2010-01-21 | 30 | 0 |
| K091458 | HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BAL | Ev3 Neurovascular | 2009-10-15 | 150 | 0 |
| K092495 | HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-431 | Ev3 Neurovascular | 2009-09-22 | 39 | 0 |
| K091504 | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS | Micrus Endovascular Corporation | 2009-06-19 | 29 | 0 |
| K090970 | FLOCONTROL , MODEL 1028 | Coaxia, Inc. | 2009-06-12 | 67 | 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