510(k) · Cleared
ClearedHansen Medical Magellan Robotic Catheter eKit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hansen Medical, Inc. · DRA Catheter, Steerable
Cleared on Feb 1, 2016 as substantially equivalent to K151463 (Hansen Medical, Inc., 2015) after a 77-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- Feb 1, 2016
- Review
- 77 days
- Class
- Class II
- Product code
- DRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K900765 (1990). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 8 generations between
- 3 generations backK132369 Magellan Robotic System, Magellan Robotic Catheter 9FRHansen Medical, Inc. · 2013 · Recalled
- 2 generations backK133552 Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic…Hansen Medical · 2014
- 1 generation backK151463 Hansen Medical Magellan Robotic Catheter 6Fr and Accessory ComponentsHansen Medical, Inc. · 2015
- This deviceK153304 Hansen Medical Magellan Robotic Catheter eKitHansen Medical, Inc. · 2016
Show all 12 generations
- Root · 12 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 11 generations backK013484 Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital…Stereotaxis, Inc. · 2002
- 10 generations backK021555 Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003
- 9 generations backK052480 Hansen Medical Catheter Control System (CCS) and Accessories, Hansen…Hansen Medical, Inc. · 2007 · Recalled
- 8 generations backK073225 Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · Recalled
- 7 generations backK090365 Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · Recalled
- 6 generations backK091808 Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc. · 2009 · Recalled
- 5 generations backK102168 Sensei X Robotic Catheter SystemHansen Medical, Inc. · 2010 · Recalled
- 4 generations backK111004 Hansen Medical Vascular Catheter Control System and CatheterHansen Medical, Inc. · 2012 · Recalled
- 3 generations backK132369 Magellan Robotic System, Magellan Robotic Catheter 9FRHansen Medical, Inc. · 2013 · Recalled
- 2 generations backK133552 Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic…Hansen Medical · 2014
- 1 generation backK151463 Hansen Medical Magellan Robotic Catheter 6Fr and Accessory ComponentsHansen Medical, Inc. · 2015
- This deviceK153304 Hansen Medical Magellan Robotic Catheter eKitHansen Medical, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K900765 | Steerocath (TM) | Ep Technologies, Inc. | 1990 | — |
| −11 | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging… | Stereotaxis, Inc. | 2002 | — |
| −10 | K021555 | Stereotaxis Niobe Magnetic Navigation System | Stereotaxis, Inc. | 2003 | — |
| −9 | K052480 | Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical… | Hansen Medical, Inc. | 2007 | 2 |
| −8 | K073225 | Sensei Catheter Control System | Hansen Medical, Inc. | 2008 | 1 |
| −7 | K090365 | Hansen Medical Artisan S Control Catheter | Hansen Medical, Inc. | 2009 | 1 |
| −6 | K091808 | Sensei Robotic Catheter System, Model 02057 | Hansen Medical, Inc. | 2009 | 1 |
| −5 | K102168 | Sensei X Robotic Catheter System | Hansen Medical, Inc. | 2010 | 1 |
| −4 | K111004 | Hansen Medical Vascular Catheter Control System and Catheter | Hansen Medical, Inc. | 2012 | 2 |
| −3 | K132369 | Magellan Robotic System, Magellan Robotic Catheter 9FR | Hansen Medical, Inc. | 2013 | 2 |
| −2 | K133552 | Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic Catheter… | Hansen Medical | 2014 | — |
| −1 | K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components | Hansen Medical, Inc. | 2015 | — |
| 0 (this device) | K153304 | Hansen Medical Magellan Robotic Catheter eKit | Hansen Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 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 DRA? 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 DRA device
- #1 K262165 FARADRIVE™ Steerable Sheath (M004PF21M402)score 13.2 · 6 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 |
|---|---|---|---|
| * | K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory ComponentsSummary page 4…he Hansen Medical Magellan Robotic Catheter eKit is substantially equivalent in intended use and method of operation to the Hansen Medical Magellan Robotic Catheter 6Fr (K151463). Hansen Medical Traditional 510(k) Submission Page 5-1 of 5 Magellan Robotic Catheter eKit… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 10 of the 18 ancestors have a recall of any class.
How does its category compare?
All DRA devicesDRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRA
89in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRA
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRA
4,018in 2025
MAUDE reports naming product code DRA, 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 | 1 | — | 0 | 6 |
| 2008 | 1 | — | 1 | 23 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 29 | 0 | 2 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 4 | 70 | 0 | 89 |
| 2013 | 0 | — | 0 | 113 |
| 2014 | 1 | — | 0 | 212 |
| 2015 | 1 | — | 0 | 350 |
| 2016 | 4 | 123 | 0 | 481 |
| 2017 | 2 | — | 0 | 625 |
| 2018 | 1 | — | 0 | 633 |
| 2019 | 2 | — | 0 | 700 |
| 2020 | 1 | — | 0 | 703 |
| 2021 | 1 | — | 0 | 741 |
| 2022 | 2 | — | 0 | 652 |
| 2023 | 3 | 89 | 0 | 788 |
| 2024 | 0 | — | 0 | 1,962 |
| 2025 | 1 | — | 0 | 4,018 |
| 2026 | 1 | — | 4 | — |
What is it indicated for?
The Hansen Medical Magellan™ Robotic Catheter eKit is intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.
The Magellan™ Robotic Catheter eKit is intended to be used with the Hansen Medical Magellan™ Robotic System and accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153304 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153304: Hansen Medical Magellan Robotic Catheter eKit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153304
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