510(k) Report

FDA applicant

Stereotaxis, Inc.

St. Louis, MO31 decisions2002–20267 recalls

FDA records 31 decisions for Stereotaxis, Inc. (St. Louis, MO) from 2002 to 2026: 29 510(k) clearances and 2 original PMA approvals. Most are in product codes DXX (System, Catheter Control, Steerable) and DQX (Wire, Guide, Catheter). Its devices cite 43 predicates, 31 of them its own earlier devices. 7 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Stereotaxis, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2007: 22008: 22010: 12013: 12014: 32015: 12019: 22020: 12025: 22026 (partial year): 3
2007high 3 (2014) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Stereotaxis, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Stereotaxis, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DXXSystem, Catheter Control, Steerable9decisions
  • DQXWire, Guide, Catheter8decisions
  • PJBCatheter Remote Control System3decisions
  • DRFCatheter, Electrode Recording, Or Probe, Electrode Recording2decisions
  • DQYCatheter, Percutaneous2decisions
  • DQKComputer, Diagnostic, Programmable2decisions

Also: NDQ (2), LPB (2), JAA (1).

Whose devices does it build on?

Its devices cite 43 predicates; 31 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 38 times; 31 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K013484Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging System, Niobe Electrophysiology…Stereotaxis, Inc. · 20025cite it
  • K042854Stereotaxis Endovascular Guide WireStereotaxis, Inc. · 20054cite it
  • K060967Niobe Magnetic Navigation System W/Navigant WorkstationStereotaxis, Inc. · 20064cite it
  • K021555Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 20034cite it
  • K122659Vdrive W/V-SonoStereotaxis, Inc. · 20133cite it
  • K071029Cardiodrive Catheter Advancement System (Cas)Stereotaxis, Inc. · 20073cite it

What has FDA decided for it lately?

  • K262744GenesisX RMNStereotaxis, Inc. · 2026
  • K253473SynchronyStereotaxis, Inc. · 2026
  • P240014MAGiC Ablation CatheterStereotaxis, Inc. · 2026
  • K251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)Stereotaxis, Inc. · 2025
  • K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc. · 2025
  • K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemStereotaxis, Inc. · 2020
  • K192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriStereotaxis, Inc. · 20191 recall
  • K183027Steerable catheter control systemStereotaxis, Inc. · 2019

All 31 as Stereotaxis, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K192775Niobe ES System, Models 001-006000-1 and 001-006100-1Sep 21, 2020Class II
  • K021363Floppy Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch…Jan 27, 2004
  • K021363Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part…Jan 27, 2004
  • K021363Floppy Cronus Endovascular Guidewire, Length 180 cm (partial coat), Diameter 0.014 inch…Jan 27, 2004
  • K021363Cronus Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part…Jan 27, 2004
  • K021363Cronus Endovascular Guidewire, Length 210 cm (partial coat), Diameter 0.014 inch, Part…Jan 27, 2004