Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MOF — Predicate Candidate Screening
42 FDA 510(k) clearances under this product code; the 50 most recent screened below.
94 daysmedian FDA review time
238 days90th percentile
42clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260223 | Aristotle Mini Guidewire | Scientia Vascular, Inc. | 2026-08-06 | 192 | 0 |
| K254006 | Drivewire 35 Guidewire | Rapid Medical Ltd. | 2026-07-17 | 214 | 0 |
| K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 | Scientia Vascular, Inc. | 2026-04-29 | 163 | 0 |
| K252317 | Zenith Micro Guidewire | Suzhou Zenith Vascular SciTech Limited | 2026-04-16 | 265 | 0 |
| K260537 | Willow 24 Guidewire | Arbor Endovascular, LLC | 2026-03-19 | 30 | 0 |
| K252122 | DCwire Micro-guidewire | Shanghai Achieva Medical Suzhou Co., Ltd. | 2026-03-16 | 252 | 0 |
| K260130 | Willow 18 Guidewire | Arbor Endovascular, LLC | 2026-02-13 | 28 | 0 |
| K252011 | CHIKAI Nexus petit | Asahi Intecc Co., Ltd. | 2026-02-02 | 220 | 0 |
| K253168 | 0.014” Willow Guidewire | Arbor Endovascular, LLC | 2025-11-26 | 61 | 0 |
| K244061 | X-Wire Guidewire | Imperative Care, Inc. | 2025-08-26 | 238 | 0 |
| K243756 | 0.014” Willow Guidewire | Arbor Endovascular, LLC | 2025-07-17 | 223 | 0 |
| K243383 | CHIKAI Nexus 014 | Asahi Intecc Co., Ltd. | 2025-04-21 | 172 | 0 |
| K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 | Scientia Vascular, Inc. | 2025-04-01 | 102 | 0 |
| K240871 | Synxess Neurovascular Guidewire | Enlight Medical Technologies (Shenzhen) Co., Ltd. | 2024-11-18 | 234 | 0 |
| K233791 | Drivewire 24 Guidewire | Rapid-Medical , Ltd. | 2024-07-11 | 226 | 0 |
| K231954 | Aristotle 18 Guidewire; Aristotle 24 Guidewire | Scientia Vascular, Inc. | 2023-08-01 | 29 | 0 |
| K222690 | SmartGUIDE deflectable hydrophilic guidewire | Artiria Medical SA | 2023-04-24 | 230 | 0 |
| K220398 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 | Scientia Vascular, LLC | 2023-03-10 | 392 | 0 |
| K222437 | Aristotle Colossus Guidewire | Scientia Vascular, Inc. | 2023-01-26 | 167 | 0 |
| K220934 | RADIFOCUS Torque Device | Terumo Medical Products (Hangzhou) Co., Ltd. | 2022-06-29 | 90 | 0 |
| K200374 | Columbus Guidewire | Rapid-Medical , Ltd. | 2020-12-14 | 304 | 0 |
| K202522 | Synchro SELECT Guidewire | Stryker Neurovascular | 2020-09-25 | 24 | 1 |
| K201487 | Traxcess 7 Mini Guidewire | MicroVention, Inc. | 2020-07-02 | 28 | 0 |
| K200547 | Traxcess 14 SELECT Guidewire | MicroVention, Inc. | 2020-04-16 | 44 | 0 |
| K191714 | ASAHI Neurovascular Guide Wire CHIKAI X 014 soft | Asahi Intecc Co., Ltd. | 2019-07-26 | 30 | 0 |
| K190843 | Synchro2 Support Guidewire | Stryker | 2019-05-01 | 30 | 8 |
| K183608 | Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 G | Scientia Vascular, LLC | 2019-03-22 | 86 | 0 |
| K183070 | ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 | Asahi Intecc Co., Ltd. | 2019-01-29 | 85 | 0 |
| K182337 | HYBRID Guidewire | Balt USA, LLC | 2018-10-04 | 37 | 0 |
| K181828 | Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 2 | Scientia Vascular, LLC | 2018-08-07 | 29 | 0 |
| K171613 | ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft | Asahi Intecc Co., Ltd. | 2017-07-01 | 30 | 0 |
| K163154 | Traxcess 7 Mini XSoft Guidewire | MicroVention, Inc. | 2016-12-09 | 29 | 0 |
| K161912 | ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft t | Asahi Intecc Co., Ltd. | 2016-10-14 | 94 | 0 |
| K161803 | Traxcess .007 Mini Guidewire | MicroVention, Inc. | 2016-09-30 | 92 | 0 |
| K160659 | ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) | Asahi Intecc Co., Ltd. | 2016-04-07 | 30 | 0 |
| K153053 | Traxcess Pro 14 Guidewire | MicroVention, Inc. | 2015-12-29 | 70 | 0 |
| K151825 | Viradius Neurowire | Mivi Neuroscience, Inc. | 2015-11-16 | 133 | 0 |
| K141751 | ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEURO | Asahi Intecc Co., Ltd. | 2015-01-30 | 214 | 0 |
| K133725 | TRAXCESS 14 GUIDEWIRE | MicroVention, Inc. | 2014-07-31 | 237 | 0 |
| K133625 | AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STAND | Codman & Shurtleff, Inc. | 2014-02-24 | 90 | 0 |
| K112979 | ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE | Asahi Intecc Co., Ltd. | 2011-12-01 | 56 | 0 |
| K110584 | ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE | Asahi Intecc Co., Ltd. | 2011-08-22 | 174 | 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