Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QJP · Predicate Candidate Screening
96 FDA 510(k) clearances under this product code; the 50 most recent screened below.
143 daysmedian FDA review time
271 days90th percentile
96clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260199 | SLIM Microcatheter | Balt USA, LLC | 2026-07-13 | 172 | 0 |
| K253901 | Millipede88 Access Catheter | Perfuze, Ltd. | 2026-07-09 | 216 | 0 |
| K261889 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | 2026-07-01 | 26 | 0 |
| K261808 | ISAAC Neurovascular Navigation Catheter | Microvention Inc. d/b/a Terumo Neuro | 2026-06-30 | 29 | 0 |
| K261549 | BOBBY Balloon Guide Catheter | MicroVention, Inc., d/b/a Terumo Neuro | 2026-06-09 | 29 | 0 |
| K253359 | Zenith Distal Access Long Sheath | Suzhou Zenith Vascular SciTech Limited | 2026-05-22 | 234 | 0 |
| K254178 | SAYA 86 Radial Access Guide Catheter | Asahi Intecc Co., Ltd. | 2026-05-11 | 139 | 0 |
| K254046 | BosCATH Support Catheter | Sonorous NV, Inc. | 2026-04-21 | 125 | 0 |
| K254223 | Next Generation 088 Catheter | Balt USA, LLC | 2026-04-16 | 108 | 0 |
| K260938 | PATH BGC | Crossroads Neurovascular, Inc. | 2026-04-15 | 26 | 0 |
| K253975 | Radical 6F Access Catheter | Maduro Medical, Inc. | 2026-04-09 | 119 | 0 |
| K253032 | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | 2026-02-11 | 142 | 0 |
| K252297 | Toro 88 Superbore Catheter | Toro Neurovascular, Inc. | 2026-01-16 | 177 | 0 |
| K251097 | V-DAC Catheter | Vesalio, Inc. | 2026-01-06 | 271 | 0 |
| K251668 | SurfRider 13 Microcatheter | Kaneka Americas Holding, Inc. | 2026-01-05 | 220 | 0 |
| K252213 | Bendit17 Microcatheter | Bend IT Technologies, Ltd. | 2025-12-03 | 141 | 0 |
| K251372 | VersaD Delivery Catheter | Unity Medical, Inc. | 2025-10-24 | 175 | 0 |
| K252569 | Carrier XL Delivery Catheter | Balt USA, LLC | 2025-10-22 | 69 | 0 |
| K250960 | DUO Microcatheter | Rev Neuro, LLC | 2025-09-08 | 161 | 0 |
| K251560 | FUBUKI XF-R Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | 2025-06-20 | 30 | 0 |
| K251240 | Branchor X Balloon Guide Catheter | Asahi Intecc Co., Ltd. | 2025-06-20 | 59 | 0 |
| K251044 | 93 NeuFlex Catheter | Piraeus Medical | 2025-05-23 | 50 | 0 |
| K242392 | PATH BGC | Crossroads Neurovascular, Inc. | 2025-05-09 | 270 | 0 |
| K242289 | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcat | Stryker Neurovascular | 2025-03-21 | 231 | 0 |
| K243593 | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | 2025-02-18 | 90 | 0 |
| K242051 | VersaD Delivery Catheter | Unity Medical, Inc. | 2025-01-17 | 189 | 0 |
| K243577 | Radical the Dude 8F Guide Catheter | Maduro Medical, Inc. | 2025-01-14 | 56 | 0 |
| K243297 | APRO 70 Swift Catheter | Alembic, LLC | 2025-01-14 | 88 | 0 |
| K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Acces | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2025-01-02 | 232 | 0 |
| K242376 | Next Generation Access Platform | Balt USA, LLC | 2024-12-30 | 143 | 1 |
| K241768 | Broadway 8 Catheter | Stryker Neurovascular | 2024-12-19 | 182 | 0 |
| K241637 | Echo Intracranial Base Catheter | Stryker Neurovascular | 2024-12-19 | 195 | 0 |
| K242033 | Access25™ Delivery Microcatheter | Penumbra, Inc. | 2024-12-11 | 153 | 0 |
| K240971 | 87 NeuGlide Catheter | Piraeus Medical | 2024-12-06 | 241 | 0 |
| K242301 | Socrates 38 Catheter | Scientia Vascular, Inc. | 2024-12-04 | 124 | 0 |
| K240746 | Neurovascular Access System Family | Q'Apel Medical, Inc. | 2024-11-20 | 246 | 0 |
| K240711 | Zipline Access Catheter | Perfuze, Ltd. | 2024-10-17 | 216 | 0 |
| K241244 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediat | Cerenovus, Inc. | 2024-10-16 | 167 | 0 |
| K240529 | 8F Modified Sheath System | Route 92 Medical, Inc. | 2024-10-02 | 222 | 0 |
| K234074 | Next Generation Access Catheter | Balt USA, LLC | 2024-07-02 | 193 | 0 |
| K240948 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Pla | Imperative Care, Inc. | 2024-06-06 | 59 | 0 |
| K232542 | Wedge XL Delivery Catheter | MicroVention, Inc. | 2024-05-16 | 268 | 0 |
| K233982 | CEREGLIDE 92 Catheter System | Cerenovus, Inc. | 2024-05-09 | 143 | 0 |
| K233924 | EMBOGUARD Balloon Guide Catheter | Neuravi Limited | 2024-04-18 | 127 | 0 |
| K233201 | MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWA | Penumbra, Inc. | 2024-03-27 | 181 | 0 |
| K231056 | Esperance Distal Access Catheter | Wallaby Medical | 2024-03-08 | 330 | 0 |
| K231218 | Distal Access Catheter | Accumedical Beijing , Ltd. | 2024-01-19 | 266 | 0 |
| K233205 | Distal Access Catheter | Shanghai Heartcare Medical Technology Co., Ltd. | 2023-12-22 | 85 | 0 |
| K233648 | Millipede 088 Access Catheter | Perfuze, Ltd. | 2023-12-14 | 30 | 0 |
| K231179 | Slinky Catheter | Anoxia Medical, Inc. | 2023-12-01 | 219 | 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