Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
MTD — Predicate Candidate Screening
34 FDA 510(k) clearances under this product code; the 50 most recent screened below.
101 daysmedian FDA review time
300 days90th percentile
34clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261012 | OptiMap Catheter - 60mm (OPTI-CATH2-60) | Cortex, Inc. | 2026-04-23 | 27 | 0 |
| K253205 | OptiMap Catheter - 50mm (OPTI-CATH2-50) | Cortex, Inc. | 2026-03-13 | 168 | 0 |
| K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009) | Medtronic | 2024-08-07 | 300 | 0 |
| K241372 | Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ | ABBOTT MEDICAL | 2024-07-09 | 55 | 0 |
| K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Ma | Biosense Webster, Inc. | 2023-07-10 | 66 | 0 |
| K223666 | Ablacath™ Mapping Catheter | Ablacon, Inc. | 2023-03-17 | 100 | 0 |
| K230253 | OPTRELL™ Mapping Catheter with TRUEref™ Technology | Biosense Webster, Inc. | 2023-03-02 | 30 | 0 |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009 | Acutus Medical, Inc. | 2022-06-21 | 463 | 0 |
| K211438 | OPTRELL Mapping Catheter with TRUEref Technology | Biosense Webster, Inc. | 2022-03-18 | 312 | 0 |
| K201806 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | Sterilmed Inc. (Johnson and Johnson) | 2021-06-23 | 357 | 0 |
| K201341 | AcQMap 3D Imaging and Mapping Catheter | Acutus Medical, Inc. | 2020-09-15 | 118 | 0 |
| K200212 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | Innovative Health, LLC | 2020-09-03 | 219 | 0 |
| K201750 | Pentaray Nav eco High-Density Mapping Catheter | Biosense Webster, Inc. | 2020-08-06 | 41 | 0 |
| K193237 | Carto Octaray Mapping Catheter with Trueref Technology | Biosense Webster, Inc. | 2020-07-31 | 249 | 0 |
| K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | St. Jude Medical, Inc. | 2018-04-23 | 258 | 0 |
| K170819 | AcQMap 3D Imaging and Mapping Catheter | Acutus Medical, Inc. | 2017-10-16 | 210 | 0 |
| K163709 | FIRMap Catheter | Abbott Electrophysiology | 2017-02-28 | 60 | 0 |
| K153093 | FIRMap Catheter | Abbott Electrophysiology | 2016-04-07 | 164 | 0 |
| K142182 | FRIMAP ADAPTER CONNECTOR (MAC) | Topera, Inc. | 2014-09-09 | 32 | 0 |
| K140733 | CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER | Boston Scientific Corporation | 2014-04-28 | 35 | 0 |
| K130827 | FIRMAP CATHETER | Topera, Inc. | 2013-10-31 | 219 | 1 |
| K123837 | PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER | Biosense Webster, Inc. | 2013-03-05 | 82 | 1 |
| K120425 | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER | Biosense Webster, Inc. | 2012-05-24 | 101 | 1 |
| K121006 | ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER | St Jude Medical | 2012-05-03 | 30 | 0 |
| K050217 | FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPA | Biosense Webster, Inc. | 2005-03-30 | 58 | 0 |
| K021232 | CONSTELLATION CATHETERS, MODEL 8031M | Boston Scientific Corp | 2002-05-16 | 28 | 1 |
| K012926 | MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 | Endocardial Solutions, Inc. | 2001-09-28 | 28 | 0 |
| K003782 | CONSTELLATION CATHETER, MODEL 8031 | Boston Scientific Corp | 2001-02-14 | 69 | 1 |
| K000277 | CONSTELLATION CATHETERS | Boston Scientific Corp | 2000-09-26 | 239 | 1 |
| K992777 | CONSTELLATION CATHETERS, MODEL 8039 | Boston Scientific Corp | 1999-11-12 | 86 | 1 |
| K990795 | MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAY | Cardiac Pathways Corp. | 1999-06-08 | 90 | 0 |
| K983456 | ENSITE 3000 SYSTEM | Endocardial Solutions, Inc. | 1999-04-21 | 203 | 0 |
| K983171 | CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM | Boston Scientific Corp | 1999-03-11 | 182 | 1 |
| K982540 | MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 70 | Cardiac Pathways Corp. | 1999-01-27 | 190 | 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