510(k) · Cleared
ClearedStereotaxis Niobe Magnetic Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stereotaxis, Inc. · DXX System, Catheter Control, Steerable
Cleared on Jan 15, 2003 as substantially equivalent to K013484 (Stereotaxis, Inc., 2002) after a 247-day review. Its family tree reaches back 2 generations to 1990. 35 later devices descend from it.
- Decided
- Jan 15, 2003
- Review
- 247 days
- Class
- Class II
- Product code
- DXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K900765 (1990). 4 ancestors in all. 35 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 1 generation backK013484 Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital…Stereotaxis, Inc. · 2002
- This deviceK021555 Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003
- Descendant · cites it directly · 27 of its ownK052480 Hansen Medical Catheter Control System (CCS) and Accessories, Hansen…Hansen Medical, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 24 of its ownK073225 Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 22 of its ownK090365 Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 19 of its ownK091808 Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc. · 2009 · Recalled
- Descendant · 5 generations on · 12 of its ownK102168 Sensei X Robotic Catheter SystemHansen Medical, Inc. · 2010 · Recalled
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K052480Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical Steerable…Hansen Medical, Inc. · 2007 · cites it directly27descendants
- K073225Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · 2 generations on24descendants
- K090365Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · 3 generations on22descendants
- K091808Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc. · 2009 · 4 generations on19descendants
- K102168Sensei X Robotic Catheter SystemHansen Medical, Inc. · 2010 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900765 | Steerocath (TM) | Ep Technologies, Inc. | 1990 | — |
| −1 | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging… | Stereotaxis, Inc. | 2002 | — |
| 0 (this device) | K021555 | Stereotaxis Niobe Magnetic Navigation System | Stereotaxis, Inc. | 2003 | — |
| +1 | K052480 | Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical… | Hansen Medical, Inc. | 2007 | 2 |
| +2 | K073225 | Sensei Catheter Control System | Hansen Medical, Inc. | 2008 | 1 |
| +3 | K090365 | Hansen Medical Artisan S Control Catheter | Hansen Medical, Inc. | 2009 | 1 |
| +4 | K091808 | Sensei Robotic Catheter System, Model 02057 | Hansen Medical, Inc. | 2009 | 1 |
| +5 | K102168 | Sensei X Robotic Catheter System | Hansen Medical, Inc. | 2010 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 DXX? 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 DXX device
- #1 K251792 Stereotaxis GenesisX RMN with Navigant ™…score 13.9 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging System… | 2002 |
What descends from it? (35)
See all 354 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052480 | Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical Steerable… | 2007 | 27 |
| K032937 | Navigant Magnetic Navigation Workstation 2.1 (NWS2) Model, 020-004500 | 2004 | 4 |
| K251792 | Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) | 2025 | 1 |
| K113628 | Amigo Remote Catheter System (RCS) & Accessories | 2012 | 1 |
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 13 years and passes through 2 companies; a new generation was cleared every 12.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K052480 (Hansen Medical, Inc., 2007) has gone furthest, with 27 descendants of its own.
- 4 other devices also cite its predicate K013484.
How does its category compare?
All DXX devicesDXX System, Catheter Control, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXX
76in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXX
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXX
1in 2024
MAUDE reports naming product code DXX, 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 | 2 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 1 | 2 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 4 | 155 | 0 | 2 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 4 | 104 | 1 | 14 |
| 2015 | 4 | 156 | 0 | 2 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 3 | 76 | 0 | 9 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Niobe MNS is intended to navigate a magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021555 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021555: Stereotaxis Niobe Magnetic Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021555
Report an extraction error
Are you the manufacturer?
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