510(k) · Cleared
ClearedNavigant Magnetic Navigation Workstation 2.1 (NWS2) Model, 020-004500
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 Jul 1, 2004 as substantially equivalent to K013484 (Stereotaxis, Inc., 2002) and 1 other predicate after a 283-day review. Its family tree reaches back 3 generations to 1990. 4 later devices descend from it.
- Decided
- Jul 1, 2004
- Review
- 283 days
- Class
- Class II
- Product code
- DXX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K900765 (1990). 5 ancestors in all. 4 later devices descend 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 deviceK032937 Navigant Magnetic Navigation Workstation 2.1 (NWS2) Model, 020-004500Stereotaxis, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK051760 Navigant Workstation with Niobe Magnetic Navigation System, Model…Stereotaxis, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK183027 Steerable catheter control systemStereotaxis, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK192775 Niobe® Magnetic Navigation System (MNS) with Navigant Workstation…Stereotaxis, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 0 of its ownK193147 Stereotaxis Genesis RMN with Navigant Workstation (NWS) and…Stereotaxis, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K051760Navigant Workstation with Niobe Magnetic Navigation System, Model NWS05Stereotaxis, Inc. · 2006 · cites it directly3descendants
- K183027Steerable catheter control systemStereotaxis, Inc. · 2019 · 2 generations on2descendants
- K192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriStereotaxis, Inc. · 2019 · 3 generations on1descendant
- K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemStereotaxis, Inc. · 2020 · 4 generations on0descendants
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) | K032937 | Navigant Magnetic Navigation Workstation 2.1 (NWS2) Model, 020-004500 | Stereotaxis, Inc. | 2004 | — |
| +1 | K051760 | Navigant Workstation with Niobe Magnetic Navigation System, Model NWS05 | Stereotaxis, Inc. | 2006 | — |
| +2 | K183027 | Steerable catheter control system | Stereotaxis, Inc. | 2019 | — |
| +3 | K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and… | Stereotaxis, Inc. | 2019 | 1 |
| +4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2019 | 2 | 0 |
| 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 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? (2)
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…Summary page 1…he physician to control the MINS. Substantial The Niobe® MNS with NWS2 is substantially equivalent to the TelstarA equivalence Magnetic Navigation System [TMNS] (K01 3484), and the NMINS (K02 1555). Continued… | 2002 |
| * | K021555 | Stereotaxis Niobe Magnetic Navigation SystemSummary page 1…magnetic device. The Navigant Navigation Workstation 2.1 [NWS2] is a modification to the Niobe* Magnetic Navigation System (K021555). The changes introduce a new software design and mode of operation, but maintain the existing tech… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051760 | Navigant Workstation with Niobe Magnetic Navigation System, Model NWS05 | 2006 | 3 |
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 14 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K051760 (Stereotaxis, Inc., 2006) has gone furthest, with 3 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 Navigant TM Navigation Workstation 2.1 [NWS2] is a component of the Niobe® MNS. The Niobe® MNS with NWS2 is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant TM feature provides an enhanced navigation interface for the physician to control the MNS.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032937 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032937: Navigant Magnetic Navigation Workstation 2.1 (NWS2) Model, 020-004500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032937
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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