Stereotaxis, Inc.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Stereotaxis, Inc.” (first 2002, latest 2026), plus 2 PMA decisions, across 9 product codes in 3 review panels. Median 510(k) review time under this name: 156 days. Since 2017 the median was 146 days, against 115 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 329 |
| 2014 | 3 | 156 |
| 2015 | 1 | 128 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 170 |
| 2020 | 1 | 113 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 147 |
| 2026 | 2 | 98 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Stereotaxis, Inc. took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXX | System, Catheter Control, Steerable | 9 | 9 |
| DQX | Wire, Guide, Catheter | 8 | 8 |
| PJB | Catheter Remote Control System | 3 | 3 |
| DQK | Computer, Diagnostic, Programmable | 2 | 2 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | 2 |
| LPB | Cardiac Ablation Percutaneous Catheter | 2 | 0 |
| NDQ | System, Catheter Or Guidewire, Steerable (Magnetic) | 2 | 2 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
Review panels
- Cardiovascular (28)
- Neurology (2)
- Radiology (1)
Most recent Stereotaxis, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262744 | GenesisX RMN | DXX | 2026-08-27 | 24 |
| K253473 | Synchrony | DQK | 2026-04-01 | 173 |
| K251792 | Stereotaxis GenesisX RMN with Navigant Workstation (NWS) | DXX | 2025-11-06 | 148 |
| K250590 | MAGiC Sweep EP Mapping Catheter | DRF | 2025-07-23 | 146 |
| K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | PJB | 2020-03-05 | 113 |
| K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri | PJB | 2019-10-30 | 30 |
| K183027 | Steerable catheter control system | PJB | 2019-09-06 | 309 |
| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono | DXX | 2015-06-17 | 128 |
| K141530 | VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS | DXX | 2014-12-18 | 192 |
| K140804 | VDRIVE WITH V-LOOP/ VDRIVE DUO | DXX | 2014-09-03 | 156 |
19 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240014 | PMA | MAGiC Ablation Catheter | 2026-01-05 |
| P050029 | PMA | HELIOS II ABLATION CATHETER | 2008-10-10 |
Recalls
7 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2020-09-21.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Stereotaxis, Inc. is the lead sponsor of 5 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06019845: The MAGiC™ Cardiac Ablation European Study (Recruiting, started 2024-01-02)
- NCT04171479: RMN Versus Manual Epicardial Retrospective PMCF (Completed, started 2020-10-02)
- NCT01656772: Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study (Completed, started 2012-08)
- NCT01131793: PowerAssert Radio-Frequency (RF) Guidewire Coronary In-Stent Chronic Total Occlusion (CTO) (Completed, started 2010-03)
- NCT00851279: Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia (Completed, started 2009-06)
SEC filings
Stereotaxis, Inc. (STXS): EDGAR filings, CIK 1289340. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Stereotaxis, Inc.?
FDA lists 29 510(k) clearances under the applicant name “Stereotaxis, Inc.” (first 2002, latest 2026), plus 2 PMA decisions, across 9 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Stereotaxis, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stereotaxis, Inc. is 156 days. Since 2017: 146 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Stereotaxis, Inc.?
The most frequent FDA product codes under this applicant name are DXX (System, Catheter Control, Steerable, 9); DQX (Wire, Guide, Catheter, 8); PJB (Catheter Remote Control System, 3).
Next steps
- See all 29 Stereotaxis, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXX, Stereotaxis, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.