510(k) · Cleared
ClearedStereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)
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 Nov 6, 2025 as substantially equivalent to K021555 (Stereotaxis, Inc., 2003) after a 148-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.
- Decided
- Nov 6, 2025
- Review
- 148 days
- Class
- Class II
- Product code
- DXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K900765 (1990). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 2 generations backK013484 Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital…Stereotaxis, Inc. · 2002
- 1 generation backK021555 Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003
- This deviceK251792 Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)Stereotaxis, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK262744 GenesisX RMNStereotaxis, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262744GenesisX RMNStereotaxis, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900765 | Steerocath (TM) | Ep Technologies, Inc. | 1990 | — |
| −2 | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging… | Stereotaxis, Inc. | 2002 | — |
| −1 | K021555 | Stereotaxis Niobe Magnetic Navigation System | Stereotaxis, Inc. | 2003 | — |
| 0 (this device) | K251792 | Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) | Stereotaxis, Inc. | 2025 | — |
| +1 | K262744 | GenesisX RMN | Stereotaxis, Inc. | 2026 | — |
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 |
|---|---|---|
| 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 K243789 LIBERTY Endovascular Robotic System (LIBERTYOS)score 13.3 · 12 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 |
|---|---|---|---|
| * | K021555 | Stereotaxis Niobe Magnetic Navigation SystemSummary page 5…510(k) Number Trade Name Product Class Product Code Primary Niobe Magnetic K021555 II DXX Predicate Navigation System… | 2003 |
| † | K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | 2020 |
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 |
|---|---|---|---|
| K262744 | GenesisX RMN | 2026 | 0 |
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 35 years and passes through 2 companies; a new generation was cleared every 12.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K262744 (Stereotaxis, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K021555.
How does its category compare?
All DXX devicesDXX System, Catheter Control, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 GenesisX RMN is intended to navigate compatible magnetic devices in the chambers of the heart and arterial and venous vasculature by orienting the device tip in a desired direction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251792 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251792: Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251792
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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