510(k) · Cleared
Recalled · Class II · 2020Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri
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 Oct 30, 2019 as substantially equivalent to K183027 (Stereotaxis, Inc., 2019) after a 30-day review. Its family tree reaches back 6 generations to 1990. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 30, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- PJB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K900765 (1990). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 5 generations backK013484 Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital…Stereotaxis, Inc. · 2002
- 4 generations backK021555 Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003
- 3 generations backK032937 Navigant Magnetic Navigation Workstation 2.1 (NWS2) Model, 020-004500Stereotaxis, Inc. · 2004
- 2 generations backK051760 Navigant Workstation with Niobe Magnetic Navigation System, Model…Stereotaxis, Inc. · 2006
- 1 generation backK183027 Steerable catheter control systemStereotaxis, Inc. · 2019
- This deviceK192775 Niobe® Magnetic Navigation System (MNS) with Navigant Workstation…Stereotaxis, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK193147 Stereotaxis Genesis RMN with Navigant Workstation (NWS) and…Stereotaxis, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemStereotaxis, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K900765 | Steerocath (TM) | Ep Technologies, Inc. | 1990 | — |
| −5 | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging… | Stereotaxis, Inc. | 2002 | — |
| −4 | K021555 | Stereotaxis Niobe Magnetic Navigation System | Stereotaxis, Inc. | 2003 | — |
| −3 | K032937 | Navigant Magnetic Navigation Workstation 2.1 (NWS2) Model, 020-004500 | Stereotaxis, Inc. | 2004 | — |
| −2 | K051760 | Navigant Workstation with Niobe Magnetic Navigation System, Model NWS05 | Stereotaxis, Inc. | 2006 | — |
| −1 | K183027 | Steerable catheter control system | Stereotaxis, Inc. | 2019 | — |
| 0 (this device) | K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and… | Stereotaxis, Inc. | 2019 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
Top candidate predicates for a new PJB device
- #1 K193147 Stereotaxis Genesis RMN with Navigant…score 0.8 · 7 generations · no Class I recall
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 |
|---|---|---|---|
| * | K183027 | Steerable catheter control systemSummary page 4…System (MNS) with Navigant™ Stereotaxis, Primary K183027 870.5700 Workstation (NWS) and Inc.… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 21, 2020 | Class II | Z-0430-2021 | Device Design | There is a potential for fire in the inside computer cabinet. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K193147 (Stereotaxis, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PJB devicesPJB Catheter Remote Control System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The Niobe System 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…
Read the full statement (112 words)
The Niobe System 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/K192775 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192775: Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192775
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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