Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PDU — Predicate Candidate Screening
57 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
264 days90th percentile
57clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252315 | Santreva™-ATK Endovascular Revasculariztion Catheter | AngioSafe, Inc. | 2025-09-22 | 59 | 0 |
| K251158 | PowerWire® 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | 2025-09-11 | 149 | 0 |
| K251376 | LimFlow ARC | LimFlow, Inc. | 2025-05-31 | 29 | 0 |
| K232562 | PowerWire Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | 2024-02-28 | 188 | 0 |
| K230159 | SoundBite® Crossing System XS Peripheral | Soundbite Medical Solutions, Inc. | 2023-08-28 | 221 | 0 |
| K230594 | Tigereye ST CTO-Crossing Catheter | Avinger, Inc. | 2023-04-25 | 53 | 0 |
| K221163 | Tunnel Crossing Catheter | Tractus Vascular, LLC | 2023-01-19 | 272 | 0 |
| K221541 | LimFlow ARC | LimFlow, Inc. | 2022-08-31 | 96 | 0 |
| K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DAB | Ra Medical Systems,Inc | 2022-06-29 | 124 | 0 |
| K211802 | GoBack Crossing Catheter | Upstream Peripheral Technologies, Ltd. | 2022-03-01 | 264 | 0 |
| K212468 | Tigereye CTO-Crossing Catheter | Avinger, Inc. | 2022-01-06 | 153 | 0 |
| K203363 | Crosser iQ CTO Recanalization System | C.R. Bard, Inc. | 2021-08-12 | 269 | 1 |
| K210664 | DABRA Laser System (DABRA Laser model RA-308 and DABRA Cathe | Ra Medical Systems,Inc | 2021-07-27 | 144 | 0 |
| K210839 | SoundBite Crossing System - Peripheral (14P) | Soundbite Medical Solutions, Inc. | 2021-04-20 | 29 | 0 |
| K201330 | Tigereye CTO-Crossing Catheter | Avinger, Inc. | 2020-09-10 | 114 | 0 |
| K192211 | SoundBite Console, SoundBite Active Wire 18 | Soundbite Medical Solution, Inc. | 2020-01-17 | 156 | 0 |
| K183357 | XableCath Crossing Catheter | Xablecath, Inc. | 2019-01-21 | 48 | 0 |
| K170349 | RA-308 Excimer Laser System, Excimer Laser Catheter | Ra Medical Systems,Inc | 2017-05-24 | 110 | 1 |
| K162418 | Pioneer Plus Catheter | Philips Volcano | 2016-12-02 | 94 | 0 |
| K161208 | CROSSER CTO Recanalization Catheter | Bard Peripheral Vacular, Inc. | 2016-05-24 | 26 | 0 |
| K150187 | ELITECROSS Support Catheter | Cordis Corporation, A Johnson & Johnson Company | 2015-05-19 | 112 | 0 |
| K150836 | OUTBACK Elite Re-Entry Catheter | Cordis Corporation, A Johnson & Johnson Co. | 2015-04-29 | 30 | 0 |
| K140438 | MICRO GUIDE CATHETER ELITE | Cordis Corp., A Johnson & Johnson Co. | 2014-11-14 | 266 | 0 |
| K140185 | OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE | Avinger, Inc. | 2014-05-01 | 97 | 0 |
| K140288 | TRUEPATH CTO DEVICE | Boston Scientific Corp | 2014-04-16 | 70 | 0 |
| K131914 | OFFROAD RE-ENTRY CATHETER SYSTEM | Boston Scientific Corp | 2013-10-31 | 127 | 0 |
| K123532 | OCELOT PIXL CATHETER | Avinger, Inc. | 2012-12-14 | 28 | 0 |
| K123462 | OCELOT CATHETER | Avinger, Inc. | 2012-12-07 | 28 | 0 |
| K122380 | OCELOT SYSTEM | Avinger, Inc. | 2012-11-07 | 93 | 0 |
| K120533 | BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES | Bridgepoint Medical | 2012-05-22 | 90 | 0 |
| K120273 | KITTYCAT CATHETER, KITTYCAT 2 CATHETER | Avinger, Inc. | 2012-03-30 | 60 | 0 |
| K113838 | WILDCAT CATHETER | Avinger, Inc. | 2012-03-12 | 75 | 0 |
| K112308 | CROSSER RECANALIZATION SYSTEM | C.R. Bard, Inc. | 2011-08-17 | 6 | 0 |
| K111338 | WILDCAT CATHETER | Avinger, Inc. | 2011-08-11 | 91 | 0 |
| K101599 | RVT CTO DEVICE | Revascular Therapeutics, Inc. | 2011-01-18 | 225 | 0 |
| K101615 | POWERWIRE RADIOFREQUENCY GUIDEWIRE | Baylis Medical Co., Inc. | 2010-07-28 | 49 | 0 |
| K101777 | PIONEER PLUS CATHETER, MODEL PLUS 120 | Medtronic Vascular | 2010-07-23 | 28 | 1 |
| K092175 | THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MOD | Flowcardia, Inc. | 2010-02-17 | 211 | 0 |
| K091119 | MODIFICATION TO THE CROSSER SYSTEM | Flowcardia, Inc. | 2009-05-15 | 28 | 0 |
| K083814 | OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 | Cordis Corp., A Johnson & Johnson Co. | 2009-01-13 | 22 | 0 |
| K082143 | MICRO GUIDE CATHETER XP | Cordis Corp. | 2008-08-25 | 26 | 0 |
| K081804 | PIONEER PLUS CATHETER | Medtronic, Inc. | 2008-08-05 | 40 | 2 |
| K072776 | THE CROSSER SYSTEM | Flowcardia, Inc. | 2007-12-07 | 70 | 1 |
| K072155 | PIONEER CATHETER | Medtronic, Inc. | 2007-10-05 | 63 | 0 |
| K071227 | CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4 | Spectranetics Corp. | 2007-07-11 | 69 | 1 |
| K071226 | 8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL | Spectranetics Corp. | 2007-06-29 | 57 | 2 |
| K060012 | CLIRPATH TURBO PERIPHERAL CATHETERS | Spectranetics Corp. | 2006-09-29 | 269 | 0 |
| K051670 | RF TUNNELER WIRE | Baylis Medical Co., Inc. | 2006-03-30 | 281 | 0 |
| K052514 | CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, | Spectranetics Corp. | 2005-10-19 | 35 | 0 |
| K052296 | CLIRPATH TURBO EXCIMER LASER CATHETERS | Spectranetics Corp. | 2005-09-02 | 10 | 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