510(k) · Cleared
ClearedStereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stereotaxis, Inc. · PJB Catheter Remote Control System
Cleared on Mar 5, 2020 as substantially equivalent to K192775 (Stereotaxis, Inc., 2019) after a 113-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Mar 5, 2020
- Review
- 113 days
- Class
- Class II
- Product code
- PJB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K900765 (1990). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 6 generations backK013484 Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital…Stereotaxis, Inc. · 2002
- 5 generations backK021555 Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003
- 4 generations backK032937 Navigant Magnetic Navigation Workstation 2.1 (NWS2) Model, 020-004500Stereotaxis, Inc. · 2004
- 3 generations backK051760 Navigant Workstation with Niobe Magnetic Navigation System, Model…Stereotaxis, Inc. · 2006
- 2 generations backK183027 Steerable catheter control systemStereotaxis, Inc. · 2019
- 1 generation backK192775 Niobe® Magnetic Navigation System (MNS) with Navigant Workstation…Stereotaxis, Inc. · 2019 · Recalled
- This deviceK193147 Stereotaxis Genesis RMN with Navigant Workstation (NWS) and…Stereotaxis, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K900765 | Steerocath (TM) | Ep Technologies, Inc. | 1990 | — |
| −6 | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging… | Stereotaxis, Inc. | 2002 | — |
| −5 | K021555 | Stereotaxis Niobe Magnetic Navigation System | Stereotaxis, Inc. | 2003 | — |
| −4 | K032937 | Navigant Magnetic Navigation Workstation 2.1 (NWS2) Model, 020-004500 | Stereotaxis, Inc. | 2004 | — |
| −3 | K051760 | Navigant Workstation with Niobe Magnetic Navigation System, Model NWS05 | Stereotaxis, Inc. | 2006 | — |
| −2 | K183027 | Steerable catheter control system | Stereotaxis, Inc. | 2019 | — |
| −1 | K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and… | Stereotaxis, Inc. | 2019 | 1 |
| 0 (this device) | K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | Stereotaxis, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PJB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriSummary page 4…5700 Product Code: PJB Classification Panel: Cardiovascular Predicate Devices: Niobe MNS (K192775) Device Stereotaxis Genesis RMN® with Navigant™ Workstation (NWS) and Cardiodrive® description System (Genesis M… | 2019 |
| † | K183027 | Steerable catheter control system | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 12 ancestors have a recall of any class.
How does its category compare?
All PJB devicesPJB Catheter Remote Control System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PJB
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PJB
Too few PJB 510(k)s in any year since 2007 to give a median.
Recalls per year · PJB
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PJB
1in 2025
MAUDE reports naming product code PJB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction. The Cardiodrive® Catheter Advancement System (CAS) is intended to automatically advance and retract compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient’s heart when…
Read the full statement (111 words)
Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction.
The Cardiodrive® Catheter Advancement System (CAS) is intended to automatically advance and retract compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient’s heart when used in conjunction with a Stereotaxis MNS.
The Cardiodrive® system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus.
The Cardiodrive® system is not intended to advance or retract non-compatible catheters and/or other non-compatible devices into the neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193147: Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193147
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026