Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LOX — Predicate Candidate Screening
87 FDA 510(k) clearances under this product code; the 50 most recent screened below.
121 daysmedian FDA review time
273 days90th percentile
87clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261759 | Euphora Rapid Exchange (RX) Balloon Dilatation Catheter | Medtronic Ireland | 2026-07-27 | 60 | 0 |
| K252116 | Firefighter™ Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | 2026-04-07 | 274 | 0 |
| K254022 | FLASH Flex™ Aorto-Ostial Angioplasty System | Verge Medical, Inc. | 2026-04-02 | 107 | 0 |
| K252295 | Ryurei | Terumo Corporation | 2026-03-27 | 247 | 0 |
| K251970 | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter | Medtronic, Ireland | 2026-01-17 | 205 | 0 |
| K242969 | Pantera Pro; Pantera LEO | Biotronik, Inc. | 2024-10-25 | 29 | 0 |
| K233499 | Sapphire NC ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-16 | 290 | 0 |
| K233505 | Sapphire ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-15 | 289 | 0 |
| K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringe | Vascular Solutions, LLC | 2024-05-31 | 192 | 0 |
| K223189 | Firefighter™ NC Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | 2023-07-21 | 282 | 0 |
| K230374 | Coronary Dilatation Balloon Catheter (VesPenetrator®), Coron | Dongguan TT Medical, Inc. | 2023-06-29 | 136 | 0 |
| K230705 | POT PTCA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2023-04-11 | 28 | 0 |
| K223022 | SC HONKYTONK PTCA Balloon Dilatation Catheter | Sino Medical Sciences Technology, Inc. | 2023-02-15 | 139 | 0 |
| K222538 | NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter | Sino Medical Sciences Technology, Inc. | 2022-12-21 | 121 | 0 |
| K220634 | NC TREK NEO Coronary Dilatation Catheter | Abbott Vascular | 2022-06-30 | 118 | 0 |
| K220629 | Emerge Monorail PTCA Dilatation Catheter | Boston Scientific | 2022-03-24 | 20 | 0 |
| K212393 | OPN NC PTCA Dilatation Catheter | Sis Medical AG | 2022-03-14 | 224 | 0 |
| K211349 | Selebrek PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2022-01-07 | 249 | 0 |
| K211807 | Sapphire NC 24 | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2021-10-14 | 125 | 0 |
| K210012 | Tamarin Blue PTCA RX Dilatation Catheter | Natec Medical , Ltd. | 2021-07-09 | 186 | 0 |
| K211393 | Selethru(TM) NC PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2021-07-02 | 58 | 0 |
| K202578 | KardiFlex NC Coronary Dilatation Catheter | Medcaptain Life Science Co., Ltd. | 2021-05-06 | 240 | 0 |
| K202619 | KardiFlex PTCA Balloon Dilatation Catheter | Medcaptain Life Science Co., Ltd. | 2021-04-29 | 231 | 0 |
| K203390 | Artimes pro Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2021-04-14 | 147 | 0 |
| K200269 | Sapphire II PRO | Orbusneich Medical Trading, Inc. | 2020-03-04 | 29 | 0 |
| K192344 | Sapphire NC Plus Coronary Dilatation Catheter | Orbusneich Medical Trading, Inc. | 2019-09-19 | 21 | 0 |
| K182699 | Selethru PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2018-11-26 | 60 | 0 |
| K180040 | NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coron | Abbott Vascular | 2018-08-24 | 231 | 0 |
| K180921 | Sapphire II PRO Balloon Dilatation Catheter | Orbusneich Medical Trading, Inc. | 2018-06-28 | 80 | 0 |
| K181023 | Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx P | Meril Life Sciences Private Limited | 2018-05-17 | 30 | 0 |
| K172264 | OTW Takeru PTCA Balloon Dilatation Catheter | KANEKA Corporation | 2018-03-19 | 235 | 0 |
| K173680 | Sapphire II PRO | Orbusneich Medical Trading, Inc. | 2018-03-01 | 90 | 0 |
| K173581 | Gallant PTCA Dilatation Catheter | Medinol, Ltd. | 2018-01-25 | 66 | 0 |
| K170941 | RX NC Takeru PTCA Balloon Dilatation Catheter | KANEKA Corporation | 2017-07-07 | 99 | 0 |
| K162625 | SeQuent Neo Percutaneous Transluminal Coronary Angioplasty ( | B. Braun Interventional Systems, Inc. | 2017-06-12 | 265 | 0 |
| K163372 | RX Takeru Balloon Dilatation Catheter | KANEKA Corporation | 2017-04-07 | 127 | 0 |
| K163660 | Pantera LEO | Biotronik, Inc. | 2017-01-26 | 30 | 0 |
| K162434 | NC Gallant PTCA Catheter | Medinol, Ltd. | 2017-01-19 | 141 | 0 |
| K163114 | Sapphire II PRO | Orbusneich Medical, Inc. | 2017-01-05 | 59 | 0 |
| K163200 | Maverick XL Percutaneous Transluminal Coronary Angioplasty M | Boston Scientific Corporation | 2016-12-14 | 29 | 0 |
| K163174 | Emerge PTCA Dilatation Catheter | Boston Scientific Corporation | 2016-12-14 | 30 | 0 |
| K160985 | Pantera Pro | Biotronik, Inc. | 2016-10-07 | 182 | 0 |
| K162209 | Sapphire NC Plus | Orbusneich Medical, Inc. | 2016-10-06 | 62 | 0 |
| K153742 | Apollo Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2016-08-08 | 224 | 0 |
| K160961 | Mozec NC-Rx PTCA Baloon Dilatation Catheter | Meril Life Sciences Private Limited | 2016-07-30 | 116 | 0 |
| K160823 | NC Quantum Apex PTCA Dilatation Catheter | Boston Scientific Corporation | 2016-06-23 | 90 | 0 |
| K153682 | Chocolate XD PTCA Balloon Catheter | Trireme Medical, LLC | 2016-06-23 | 184 | 0 |
| K152485 | FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini O | Ostial Corporation | 2016-02-16 | 169 | 0 |
| K141933 | FILAO NC RX PTCA DILATATION CATHETER | Natec Medical , Ltd. | 2015-06-28 | 347 | 0 |
| K150292 | Chocolate PTCA Balloon Catheter | Trireme Medical, LLC | 2015-04-09 | 62 | 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