Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LIT — Predicate Candidate Screening
403 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
225 days90th percentile
403clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260304 | WAVE PTA Balloon Catheter | WAVE Medical AG | 2026-05-20 | 110 | 0 |
| K252512 | Armada™ 14 NC PTA Catheter | ABBOTT MEDICAL | 2026-02-13 | 186 | 0 |
| K251915 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | 2025-12-18 | 178 | 0 |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peri | Biotronik, Inc. | 2025-04-04 | 25 | 0 |
| K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet | Brosmed Medical Co., Ltd. | 2025-02-27 | 90 | 0 |
| K241040 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | 2024-12-18 | 246 | 0 |
| K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Creagh Medical Ltd. Dba Surmodics, Inc. | 2024-11-15 | 92 | 0 |
| K241740 | Finesse Injectable™ PTA Balloon Dilatation Catheter | Summa Therapeutics | 2024-07-16 | 29 | 1 |
| K241711 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | 2024-07-11 | 27 | 0 |
| K241683 | Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H749390 | Boston Scientific Corporation | 2024-07-10 | 29 | 0 |
| K241025 | JADE PLUS PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-06-11 | 57 | 0 |
| K231402 | HP PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2023-12-20 | 219 | 0 |
| K230263 | Finesse™ Injectable PTA Balloon Dilatation Catheter | Summa Therapeutics, LLC | 2023-05-26 | 115 | 1 |
| K214009 | D·Kaptain PTA High Pressure Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | 2023-04-05 | 516 | 0 |
| K230191 | Arise™ UHP Dilatation Catheter | Creagh Medical, Ltd. | 2023-03-22 | 57 | 0 |
| K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter | Biotronik, Inc. | 2023-02-16 | 218 | 0 |
| K223177 | Highlander™ 014 PTA Balloon Dilatation Catheter | C.R. Bard, Inc. | 2023-01-20 | 101 | 0 |
| K221245 | PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2022-12-14 | 226 | 0 |
| K221414 | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | Silk Road Medical, Inc. | 2022-09-02 | 109 | 0 |
| K221832 | SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatati | Cordis US Corp | 2022-08-22 | 60 | 0 |
| K212215 | Tiche PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2022-07-19 | 369 | 0 |
| K214038 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | 2022-07-06 | 195 | 0 |
| K220410 | Ebony HP PTA OTW 0.035 Catheter | Natec Medical , Ltd. | 2022-06-29 | 135 | 0 |
| K221339 | Paladin Carotid Post-Dilation Balloon System with Integrated | Contego Medical, Inc. | 2022-06-09 | 31 | 0 |
| K221057 | Viatrac 14 Plus Peripheral Dilatation Catheter | Abbott Vascular | 2022-05-05 | 24 | 0 |
| K213631 | Chocolate PTA Balloon Catheter | Medtronic, Inc. | 2021-12-15 | 28 | 0 |
| K201246 | PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) | Qualimed USA, LLC | 2021-08-03 | 452 | 0 |
| K211044 | Sublime Radial Access 018 RX Dilatation Catheter | Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, | 2021-06-16 | 69 | 0 |
| K210626 | SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilat | Cordis Corporation | 2021-04-23 | 52 | 0 |
| K202231 | JADE | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2020-12-10 | 125 | 0 |
| K202800 | Pacific Plus PTA Catheter | Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) | 2020-11-18 | 56 | 0 |
| K201377 | SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatat | Cordis Corporation | 2020-10-09 | 136 | 0 |
| K201170 | Athletis PTA Balloon Dilatation Catheter | Boston Scientific Corporation | 2020-09-15 | 137 | 0 |
| K201333 | SABER .035 PTA Dilatation Catheter | Cordis Corporation | 2020-09-11 | 115 | 0 |
| K201794 | Jade | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2020-07-28 | 28 | 0 |
| K192399 | Infinity Angioplasty Balloon Catheter | Infinity Angioplasty Balloon Company, LLC | 2020-05-20 | 260 | 0 |
| K200700 | Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Tra | Creagh Medical, Ltd. | 2020-05-14 | 58 | 0 |
| K191275 | All’InCath 035M PTA Balloon Dilatation Catheter | Nexstep Medical | 2020-01-15 | 247 | 0 |
| K192907 | Advocate PTA Catheter | Merit Medical Systems, Inc. | 2019-11-26 | 42 | 0 |
| K190037 | Cronus HP PTA Balloon Catheter | Nipro Medical Corporation | 2019-10-24 | 289 | 0 |
| K192318 | Ultraverse 014 and 018 PTA Balloon Dilatation Catheters | Bard Peripheral Vascular, Inc. | 2019-10-03 | 38 | 0 |
| K190753 | EverCrossTM 0.035 OTW PTA Dilatation Catheter | Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) | 2019-04-23 | 29 | 0 |
| K181529 | Vanguard IEP Peripheral Balloon Angioplasty System with Inte | Contego Medical, LLC | 2018-12-06 | 178 | 0 |
| K181128 | Paladin Carotid Post-dilation Balloon System with Integrated | Contego Medical, LLC | 2018-09-06 | 129 | 0 |
| K181323 | Atlas Gold PTA Dilatation Catheter | C.R. Bard, Inc. | 2018-08-03 | 77 | 0 |
| K180007 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Creagh Medical, Ltd. | 2018-04-19 | 107 | 0 |
| K173515 | Admiral Xtreme | Medtronic Vascular | 2018-04-12 | 149 | 0 |
| K173894 | Jade PTA Balloon Dilatation Catheter | Orbusneich Medical Trading, Inc. | 2018-02-09 | 50 | 0 |
| K172494 | PROTEUS PTA Balloon Catheter with Embolic Capture Feature | Angioslide, Ltd. | 2017-12-15 | 119 | 0 |
| K173621 | Advocate PTA Catheter | Merit Medical Systems, Inc. | 2017-12-13 | 21 | 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