510(k) · Cleared
ClearedTelstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging System, Niobe Electrophysiology Mapping Cath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stereotaxis, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on May 2, 2002 as substantially equivalent to K924125 (Catheter Research C/O Burditt, Bowles & Radzius, 1993) and 2 other predicates after a 195-day review. Its family tree reaches back 1 generation to 1990. 39 later devices descend from it.
- Decided
- May 2, 2002
- Review
- 195 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K900765 (1990). 3 ancestors in all. 39 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- This deviceK013484 Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital…Stereotaxis, Inc. · 2002
- Descendant · cites it directly · 35 of its ownK021555 Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003
- Descendant · 2 generations on · 27 of its ownK052480 Hansen Medical Catheter Control System (CCS) and Accessories, Hansen…Hansen Medical, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 24 of its ownK073225 Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 22 of its ownK090365 Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · Recalled
- Descendant · 5 generations on · 19 of its ownK091808 Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc. · 2009 · Recalled
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K021555Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003 · cites it directly35descendants
- K052480Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical Steerable…Hansen Medical, Inc. · 2007 · 2 generations on27descendants
- K073225Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · 3 generations on24descendants
- K090365Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · 4 generations on22descendants
- K091808Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc. · 2009 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900765 | Steerocath (TM) | Ep Technologies, Inc. | 1990 | — |
| 0 (this device) | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging… | Stereotaxis, Inc. | 2002 | — |
| +1 | K021555 | Stereotaxis Niobe Magnetic Navigation System | Stereotaxis, Inc. | 2003 | — |
| +2 | K052480 | Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical… | Hansen Medical, Inc. | 2007 | 2 |
| +3 | K073225 | Sensei Catheter Control System | Hansen Medical, Inc. | 2008 | 1 |
| +4 | K090365 | Hansen Medical Artisan S Control Catheter | Hansen Medical, Inc. | 2009 | 1 |
| +5 | K091808 | Sensei Robotic Catheter System, Model 02057 | Hansen Medical, Inc. | 2009 | 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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 | 3 | 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 DRF? 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 DRF device
- #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.6 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K924125 | Cri Electronic Control SystemSummary page 2…Niobe Catheter are substantially equivalent to the following cleared medical devices: Stereotaxis Device Predicate Device Predicate 510(k) No. MNS Catheter Research CRI K924125 Electronic Control System Telstar Bi-plane OEC Medical Systems K974355 Imaging System IMDIS Niobe Catheter EP Technologies K90076… | 1993 |
| * | K974355 | Interventional Mobile Digital Imaging System (Herein Called Imdis)Summary page 2…dical devices: Stereotaxis Device Predicate Device Predicate 510(k) No. MNS Catheter Research CRI K924125 Electronic Control System Telstar Bi-plane OEC Medical Systems K974355 Imaging System IMDIS Niobe Catheter EP Technologies K900765 Steerocath The Magnetic Navigation System employs application of mag… | 1998 |
| * | K900765 | Steerocath (TM)Summary page 2…e 510(k) No. MNS Catheter Research CRI K924125 Electronic Control System Telstar Bi-plane OEC Medical Systems K974355 Imaging System IMDIS Niobe Catheter EP Technologies K900765 Steerocath The Magnetic Navigation System employs application of magnetic fields to orient the distal tip of a magnetically actu… | 1990 |
What descends from it? (39)
See all 395 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021555 | Stereotaxis Niobe Magnetic Navigation System | 2003 | 35 |
| K032937 | Navigant Magnetic Navigation Workstation 2.1 (NWS2) Model, 020-004500 | 2004 | 4 |
| K250590 | MAGiC Sweep™ EP Mapping Catheter | 2025 | 0 |
| K051373 | Cronus Guidewire, Model 001-001470-1 | 2005 | 0 |
| K022565 | Telstar Biplane Digital Imaging System [Tis] Model 030-000915 | 2002 | 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?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K021555 (Stereotaxis, Inc., 2003) has gone furthest, with 35 descendants of its own.
How does its category compare?
All DRF devicesDRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRF
45in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRF
508in 2025
MAUDE reports naming product code DRF, 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 | — | 2 | 120 |
| 2008 | 2 | — | 4 | 176 |
| 2009 | 7 | 243 | 0 | 122 |
| 2010 | 5 | 65 | 0 | 130 |
| 2011 | 3 | 190 | 6 | 245 |
| 2012 | 1 | — | 0 | 402 |
| 2013 | 2 | — | 0 | 310 |
| 2014 | 1 | — | 2 | 349 |
| 2015 | 3 | 29 | 1 | 327 |
| 2016 | 8 | 175 | 0 | 383 |
| 2017 | 7 | — | 0 | 458 |
| 2018 | 1 | — | 0 | 723 |
| 2019 | 10 | 163 | 0 | 669 |
| 2020 | 4 | — | 0 | 651 |
| 2021 | 12 | 124 | 0 | 625 |
| 2022 | 8 | 283 | 0 | 613 |
| 2023 | 5 | 45 | 0 | 685 |
| 2024 | 4 | — | 0 | 623 |
| 2025 | 3 | — | 0 | 508 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The 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.
The Telstar™ Bi-plane Imaging System provides the utility of fluoroscopic imaging of vascular systems for applications including vascular angiography and electrophysiology (EP) studies. This x-ray system may be used stand-alone, or in conjunction with an associated Stereotaxis Magnetic Navigation System
The Niobe EP Catheter is intended for intracardiac electrophysiological recording and/or stimulation for pacing in the right heart.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013484 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013484: Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging System, Niobe Electrophysiology Mapping Cath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013484
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026