510(k) · Cleared
Recalled · Class II · 2016Magellan Robotic System, Magellan Robotic Catheter 9FR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hansen Medical, Inc. · DXX System, Catheter Control, Steerable
Cleared on Sep 27, 2013 as substantially equivalent to K111004 (Hansen Medical, Inc., 2012) after a 59-day review. Its family tree reaches back 9 generations to 1990. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 27, 2013
- Review
- 59 days
- Class
- Class II
- Product code
- DXX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 9 generations to K900765 (1990). 15 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 5 generations between
- 3 generations backK091808 Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc. · 2009 · Recalled
- 2 generations backK102168 Sensei X Robotic Catheter SystemHansen Medical, Inc. · 2010 · Recalled
- 1 generation backK111004 Hansen Medical Vascular Catheter Control System and CatheterHansen Medical, Inc. · 2012 · Recalled
- This deviceK132369 Magellan Robotic System, Magellan Robotic Catheter 9FRHansen Medical, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK141614 Magellan Robotic SystemHansen Medical · 2014 · Recalled
- Descendant · 2 generations on · 2 of its ownK152999 CorPath 200 SystemCorindus, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK133552 Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic…Hansen Medical · 2014
- Descendant · 3 generations on · 1 of its ownK173288 CorPath GRX SystemCorindus, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK151463 Hansen Medical Magellan Robotic Catheter 6Fr and Accessory ComponentsHansen Medical, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 8 generations backK013484 Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital…Stereotaxis, Inc. · 2002
- 7 generations backK021555 Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003
- 6 generations backK052480 Hansen Medical Catheter Control System (CCS) and Accessories, Hansen…Hansen Medical, Inc. · 2007 · Recalled
- 5 generations backK073225 Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · Recalled
- 4 generations backK090365 Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · Recalled
- 3 generations backK091808 Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc. · 2009 · Recalled
- 2 generations backK102168 Sensei X Robotic Catheter SystemHansen Medical, Inc. · 2010 · Recalled
- 1 generation backK111004 Hansen Medical Vascular Catheter Control System and CatheterHansen Medical, Inc. · 2012 · Recalled
- This deviceK132369 Magellan Robotic System, Magellan Robotic Catheter 9FRHansen Medical, Inc. · 2013
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K141614Magellan Robotic SystemHansen Medical · 2014 · cites it directly5descendants
- K152999CorPath 200 SystemCorindus, Inc. · 2016 · 2 generations on2descendants
- K133552Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic Catheter 6FR…Hansen Medical · 2014 · cites it directly2descendants
- K173288CorPath GRX SystemCorindus, Inc. · 2018 · 3 generations on1descendant
- K151463Hansen Medical Magellan Robotic Catheter 6Fr and Accessory ComponentsHansen Medical, Inc. · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K900765 | Steerocath (TM) | Ep Technologies, Inc. | 1990 | — |
| −8 | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging… | Stereotaxis, Inc. | 2002 | — |
| −7 | K021555 | Stereotaxis Niobe Magnetic Navigation System | Stereotaxis, Inc. | 2003 | — |
| −6 | K052480 | Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical… | Hansen Medical, Inc. | 2007 | 2 |
| −5 | K073225 | Sensei Catheter Control System | Hansen Medical, Inc. | 2008 | 1 |
| −4 | K090365 | Hansen Medical Artisan S Control Catheter | Hansen Medical, Inc. | 2009 | 1 |
| −3 | K091808 | Sensei Robotic Catheter System, Model 02057 | Hansen Medical, Inc. | 2009 | 1 |
| −2 | K102168 | Sensei X Robotic Catheter System | Hansen Medical, Inc. | 2010 | 1 |
| −1 | K111004 | Hansen Medical Vascular Catheter Control System and Catheter | Hansen Medical, Inc. | 2012 | 2 |
| 0 (this device) | K132369 | Magellan Robotic System, Magellan Robotic Catheter 9FR | Hansen Medical, Inc. | 2013 | — |
| +1 | K141614 | Magellan Robotic System | Hansen Medical | 2014 | 2 |
| +2 | K152999 | CorPath 200 System | Corindus, Inc. | 2016 | — |
| +1 | K133552 | Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic Catheter… | Hansen Medical | 2014 | — |
| +3 | K173288 | CorPath GRX System | Corindus, Inc. | 2018 | — |
| +2 | K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components | Hansen Medical, Inc. | 2015 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K111004 | Hansen Medical Vascular Catheter Control System and CatheterSummary page 1…ubstantially equivalent in intended use and method of operation to the cleared Magellan System (Magellan Robotic System and Magellan Robotic Catheter 9F7r) cleared under K1 11004. Hansen Medical Special 51 0(k) Submission Section 7, Page 1 of 4 Magellan TM System… | 2012 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2016 | Class II | Z-1564-2016 | Under Investigation by firm | Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy. |
| Mar 18, 2015 | Class II | Z-1449-2015 | Software design | Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event during a retraction operation of catheter. Retraction of catheter may not stop… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 9 of the 15 ancestors have a recall of any class.
- Of its descendants, K141614 (Hansen Medical, 2014) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K111004.
How does its category compare?
All DXX devicesDXX System, Catheter Control, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Magellan Robotic System: The Hansen Medical Magellan Robotic System and accessory components are 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 System is intended to be used with compatible Hansen Medical robotically steerable catheters. Magellan Robotic Catheter 9Fr: The Hansen Medical Magellan Robotic…
Read the full statement (110 words)
Magellan Robotic System: The Hansen Medical Magellan Robotic System and accessory components are 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 System is intended to be used with compatible Hansen Medical robotically steerable catheters.
Magellan Robotic Catheter 9Fr: The Hansen Medical Magellan Robotic Catheter 9Fr 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 9Fr 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/K132369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132369: Magellan Robotic System, Magellan Robotic Catheter 9FR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132369
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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