Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DQX — Predicate Candidate Screening
766 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
238 days90th percentile
766clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253667 | Accoat Guide Wire | Sp Medical A/S | 2026-07-14 | 235 | 0 |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide Wire | Merit Medical Ireland , Ltd. | 2026-07-13 | 56 | 0 |
| K254137 | InQwire Amplatz Guide Wire | Merit Medical Ireland, Ltd. | 2026-05-22 | 151 | 0 |
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide | FMD Co., Ltd. | 2026-03-20 | 30 | 0 |
| K253746 | Enroute 0.014'' Transcarotid Guidewire | Lake Region Medical | 2026-03-19 | 114 | 0 |
| K253262 | EmeryGlide™ (EG18008901) | Nano4imaging GmbH | 2026-03-06 | 158 | 0 |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | Merit Medical Ireland, Ltd. | 2026-01-31 | 60 | 0 |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super | Merit Medical Ireland, Ltd. | 2026-01-21 | 261 | 0 |
| K252674 | Solo Pace Fusion System (SOLOFUSE1) | Solo Pace, Inc. | 2026-01-09 | 137 | 0 |
| K251596 | Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps | 2025-11-09 | 166 | 0 |
| K250203 | SureAx-Guide™ | Sureax Medical, LLC | 2025-10-17 | 266 | 0 |
| K250031 | Amplatzer Guidewire | ABBOTT MEDICAL | 2025-10-03 | 269 | 0 |
| K251181 | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashw | Merit Medical Ireland, Ltd. | 2025-08-29 | 135 | 0 |
| K250552 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 | ABBOTT MEDICAL | 2025-07-25 | 150 | 0 |
| K250075 | Medtronic Stedi Extra Support Guidewire | Medtronic, Inc. | 2025-06-13 | 154 | 0 |
| K243733 | SION blue PLUS | Asahi Intecc Co., Ltd. | 2025-04-02 | 119 | 0 |
| K241962 | Crossloop | Asahi Intecc Co., Ltd. | 2025-03-27 | 267 | 0 |
| K242597 | CROSSLEAD 0.018inch | Asahi Intecc Co., Ltd. | 2025-03-05 | 187 | 0 |
| K241702 | CROSSLEAD 0.014inch | Asahi Intecc Co., Ltd. | 2025-02-06 | 238 | 0 |
| K241521 | Prelude Small O.D. Introducer Guide Wire | Merit Medical Systems, Inc. | 2024-12-10 | 195 | 0 |
| K242824 | PTFE Guidewire | Lake Region Medical | 2024-12-06 | 79 | 0 |
| K240818 | R2P Radifocus Glidewire Advantage | Terumo Corporation | 2024-11-26 | 246 | 0 |
| K240997 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 | ABBOTT MEDICAL | 2024-11-06 | 209 | 0 |
| K241784 | Arrow® Nitinol Wire | Teleflex Medical | 2024-09-18 | 90 | 0 |
| K240859 | Glidewire GT-R | Terumo Corporation | 2024-08-21 | 146 | 0 |
| K241510 | CROSSLEAD Tracker | Asahi Intecc Co., Ltd. | 2024-08-14 | 77 | 0 |
| K240387 | MINAMO blue; MINAMO viola | Asahi Intecc Co., Ltd. | 2024-06-21 | 134 | 0 |
| K240460 | FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) | FMD Co., Ltd. | 2024-06-13 | 118 | 0 |
| K240864 | PacePro Wire | Opsens, Inc. | 2024-05-24 | 57 | 0 |
| K232662 | BNLE Hydrophilic Jacketed Peripheral Guidewire | Biomerics Nle | 2024-05-14 | 257 | 0 |
| K230418 | Mighty Wire Guide Wire | Merit Medical Systems, Inc. | 2023-10-28 | 254 | 0 |
| K232570 | Steerant™ Super Stiff Guidewire | Medtronic Vascular | 2023-10-24 | 61 | 0 |
| K232574 | VASSALLO GT Crossing14 | Filmec Co. , Ltd. | 2023-10-11 | 47 | 0 |
| K232578 | VASSALLO GT 018 G12; VASSALLO GT 018 G30 | Filmec Co. , Ltd. | 2023-10-11 | 47 | 0 |
| K230377 | CROSSLEAD Penetration Peripheral Guide Wire | Asahi Intecc Co., Ltd. | 2023-07-20 | 157 | 0 |
| K223791 | TalWire | Embrace Medical , Ltd. | 2023-07-14 | 207 | 0 |
| K230637 | Wattson temporary pacing guidewire (2250) | Vascular Solutions, LLC | 2023-05-05 | 59 | 0 |
| K221390 | BNLE Access Guidewire | Biomerics Nle | 2023-04-28 | 350 | 0 |
| K223432 | Vassallo GT 018 Hybrid | Filmecc Co., Ltd. | 2023-03-09 | 115 | 0 |
| K213898 | ProTrack Pigtail Wire | Baylis Medical Company, Inc. | 2023-03-01 | 442 | 0 |
| K221351 | Mechanical Guidewire | Baylis Medical Company, Inc. | 2022-12-19 | 223 | 0 |
| K222631 | VASSALLO GT EXT | Filmecc Co., Ltd. | 2022-10-26 | 56 | 0 |
| K221575 | Pre-Formed Blue | Lake Region Medical | 2022-10-07 | 128 | 0 |
| K212615 | EpiFaith CV | Flat Medical Co., Ltd. | 2022-09-21 | 399 | 0 |
| K213854 | SavvyWire | Opsens, Inc. | 2022-09-14 | 278 | 0 |
| K213868 | ASAHI Gladius Mongo18 PV ES | Asahi Intecc Co., Ltd. | 2022-09-06 | 270 | 0 |
| K221917 | Stent Positioning Assistance System (SPAS) | Seven Sons , Ltd. | 2022-08-19 | 50 | 0 |
| K213315 | CROSSLEAD Peripheral Guide Wire | Asahi Intecc Co., Ltd. | 2022-07-01 | 270 | 0 |
| K213949 | VASSALLO GT 018 Floppy | Filmecc Co., Ltd. | 2022-06-30 | 195 | 0 |
| K212268 | FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Ext | FMD Co., Ltd. | 2022-05-27 | 311 | 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