Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KRA — Predicate Candidate Screening
175 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
266 days90th percentile
175clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261610 | Verge™ Microcatheter | Instylla, Inc. | 2026-06-11 | 28 | 0 |
| K260771 | TruSelect™ 2.6 Microcatheter | Boston Scientific Corporation | 2026-05-15 | 67 | 0 |
| K250794 | InVera Infusion Device | Invera Medical | 2026-03-12 | 363 | 0 |
| K243534 | Micro Catheter | Suzhou Zenith Vascular SciTech Limited | 2025-07-30 | 257 | 0 |
| K231821 | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20- | Transit Scientific, LLC | 2023-11-29 | 161 | 0 |
| K231279 | Peregrine System Infusion Catheter 4-7 mm, Peregrine System | Ablative Solutions, Inc. | 2023-07-05 | 63 | 0 |
| K231148 | ScleroSafe™ 150 mm, ScleroSafe™ 350 mm | Vvt Medical , Ltd. | 2023-06-20 | 60 | 0 |
| K230957 | TriSalus TriNav® LV Infusion System | Trisalus Life Sciences | 2023-05-02 | 28 | 0 |
| K223139 | Wallaby 017 Micro Catheter | Wallaby Medical | 2023-04-25 | 203 | 0 |
| K223176 | Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration | Argon Medical Devices, Inc. | 2023-04-10 | 181 | 0 |
| K230636 | Maestro Microcatheter | Merit Medical System, Inc. | 2023-03-30 | 23 | 0 |
| K222679 | Vericor Support Catheter | Vascupatent Medical (Shenzhen) Co., Ltd. | 2022-11-07 | 62 | 0 |
| K213435 | MAGIC Flow-Dependent Microcatheter | Balt USA, LLC | 2022-07-19 | 270 | 0 |
| K213442 | Extroducer Infusion Catheter System | SmartWise Sweden AB | 2022-06-10 | 228 | 0 |
| K214025 | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter | Medos International SARL | 2022-04-12 | 111 | 0 |
| K212719 | Micro Catheter and Guidewire System | Suzhou Hengrui Hongyuan Medical Co., Ltd. | 2022-04-11 | 227 | 0 |
| K211110 | Agile Devices Angler Steerable, Deflectable Microcatheter | Agile Devices, Inc. | 2022-01-07 | 268 | 0 |
| K210838 | PROWLER SELECT PLUS; PROWLER EX | Medos International SARL | 2021-08-25 | 156 | 0 |
| K210339 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2021-08-02 | 178 | 0 |
| K211525 | SwiftNINJA Steerable Microcatheter | Merit Medical Systems, Inc. | 2021-07-16 | 60 | 0 |
| K210808 | Instylla Microcatheter 1.2 | Instylla, Inc. | 2021-04-15 | 29 | 0 |
| K210114 | Rebar Micro Catheter | Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular | 2021-02-16 | 28 | 0 |
| K202366 | MAGIC Infusion Catheter | Balt USA, LLC | 2021-01-29 | 163 | 0 |
| K202318 | Marathon Flow Directed Micro Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-09-14 | 28 | 0 |
| K193082 | Fountain ValveTip Infusion Catheter | Merit Medical Systems, Inc. | 2020-08-07 | 276 | 0 |
| K201907 | ClariVein IC | Merit Medical Systems, Inc. | 2020-08-06 | 28 | 0 |
| K201792 | TRUSELECT Microcatheter | Boston Scientific Corporation | 2020-07-28 | 28 | 0 |
| K200582 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2020-06-25 | 111 | 0 |
| K200744 | Instylla Microcatheter | Instylla, Inc. | 2020-04-21 | 29 | 0 |
| K191305 | Hereaeus Poseidon Microcatheter | Heraeus Medical Components, LLC | 2019-12-19 | 219 | 0 |
| K193107 | TriSalus Infusion System | Trisalus Life Sciences | 2019-12-03 | 25 | 0 |
| K191731 | Instylla Microcatheter | Instylla, Inc. | 2019-08-13 | 46 | 0 |
| K182071 | Multi-Sideport Catheter Infusion Set | Cook Incorporated | 2019-04-25 | 267 | 0 |
| K181684 | VAMP Plus Venous/Arterial Blood Management Protection System | Edwards Lifesciences, LLC | 2018-11-08 | 135 | 1 |
| K180275 | VAMP Optima closed blood sampling system | Edwards Lifesciences, LLC | 2018-10-24 | 266 | 0 |
| K173586 | VAMP Venous/Arterial Blood Management Protection System | Edwards Lifesciences, LLC | 2018-04-05 | 136 | 0 |
| K171665 | Microcatheter and guide-wire system | Suzhou Hengrui Disheng Medical Co., Ltd. | 2018-01-11 | 220 | 0 |
| K170931 | CXI TriForce Peripheral Crossing Set | Cook Incorporated | 2017-11-13 | 229 | 0 |
| K172081 | Maestro Microcatheter | Merit Medical Systems, Inc. | 2017-08-04 | 25 | 1 |
| K163701 | Direxion and Direxion HI-FLO Torqueable Microcatheters | Boston Scientific Corporation | 2017-05-16 | 138 | 0 |
| K161967 | FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm | Callisyn Biomedical, Inc. | 2017-01-27 | 193 | 0 |
| K161962 | VAMP Venous/Arterial Blood Management Protection System | Edwards Lifesciences, LLC | 2016-11-28 | 133 | 0 |
| K160884 | CXI Support Catheter | Cook Incorporated | 2016-11-22 | 236 | 0 |
| K161921 | SwiftNINJA Microcatheter | Merit Medical Systems, Inc. | 2016-11-04 | 114 | 0 |
| K161402 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2016-08-18 | 90 | 0 |
| K161801 | CrossCath Support Catheter | Cook Incorporated | 2016-07-29 | 29 | 4 |
| K153501 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2016-04-15 | 130 | 0 |
| K152625 | MMS Guide Catheter | Micro Medical Solutions, Inc. | 2016-03-09 | 176 | 0 |
| K153502 | ClariVein IC | Vascular Insights, LLC | 2016-01-06 | 30 | 0 |
| K142259 | Direxion Torqueable Microcatheter | Boston Scientific Corp | 2014-09-10 | 27 | 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