Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stereotaxis, Inc. — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
159 daysmedian FDA review time
310 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253473 | Synchrony | Stereotaxis, Inc. | 2026-04-01 | 173 | 0 |
| K251792 | Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) | Stereotaxis, Inc. | 2025-11-06 | 148 | 0 |
| K250590 | MAGiC Sweep™ EP Mapping Catheter | Stereotaxis, Inc. | 2025-07-23 | 146 | 0 |
| K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and | Stereotaxis, Inc. | 2020-03-05 | 113 | 0 |
| K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workst | Stereotaxis, Inc. | 2019-10-30 | 30 | 0 |
| K183027 | Steerable catheter control system | Stereotaxis, Inc. | 2019-09-06 | 309 | 0 |
| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono | Stereotaxis, Inc. | 2015-06-17 | 128 | 0 |
| K141530 | VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS | Stereotaxis, Inc. | 2014-12-18 | 192 | 0 |
| K140804 | VDRIVE WITH V-LOOP/ VDRIVE DUO | Stereotaxis, Inc. | 2014-09-03 | 156 | 0 |
| K133396 | VDRIVE WITH V-SONO | Stereotaxis, Inc. | 2014-02-06 | 92 | 0 |
| K122659 | VDRIVE W/V-SONO | Stereotaxis, Inc. | 2013-07-26 | 329 | 0 |
| K093092 | ODYSSEY WORKSTATION | Stereotaxis, Inc. | 2010-01-21 | 112 | 0 |
| K080637 | POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS | Stereotaxis, Inc. | 2008-08-12 | 159 | 0 |
| K072371 | ODYSSEY WORKSTATION | Stereotaxis, Inc. | 2007-11-14 | 83 | 0 |
| K071029 | CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS) | Stereotaxis, Inc. | 2007-08-24 | 135 | 0 |
| K060967 | NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION | Stereotaxis, Inc. | 2006-10-19 | 195 | 0 |
| K042850 | CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STE | Stereotaxis, Inc. | 2006-08-09 | 663 | 0 |
| K051760 | NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, | Stereotaxis, Inc. | 2006-05-05 | 310 | 0 |
| K051373 | CRONUS GUIDEWIRE, MODEL 001-001470-1 | Stereotaxis, Inc. | 2005-12-09 | 197 | 0 |
| K051374 | CARDIODRIVE CATHETER ADVANCEMENT SYSTEM | Stereotaxis, Inc. | 2005-06-23 | 28 | 0 |
| K043457 | MODIFICATION TO ENDOVASCULAR GUIDE WIRE | Stereotaxis, Inc. | 2005-02-28 | 75 | 0 |
| K042854 | STEREOTAXIS ENDOVASCULAR GUIDE WIRE | Stereotaxis, Inc. | 2005-02-08 | 116 | 0 |
| K032937 | NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 0 | Stereotaxis, Inc. | 2004-07-01 | 283 | 0 |
| K021802 | STEREOTAXIS CATHETER ADVANCER SYSTEM | Stereotaxis, Inc. | 2003-04-08 | 309 | 0 |
| K021555 | STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM | Stereotaxis, Inc. | 2003-01-15 | 247 | 0 |
| K021363 | ENDOVASCULAR GUIDE WIRE | Stereotaxis, Inc. | 2002-11-27 | 211 | 6 |
| K022565 | TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-00091 | Stereotaxis, Inc. | 2002-10-08 | 67 | 0 |
| K013484 | TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE | Stereotaxis, Inc. | 2002-05-02 | 195 | 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