510(k) · Cleared
Recalled · Class II · 2016Hansen Medical Vascular Catheter Control System and Catheter
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 May 29, 2012 as substantially equivalent to K080415 (Terumo Medical Corp., 2008) and 1 other predicate after a 414-day review. Its family tree reaches back 8 generations to 1990. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- May 29, 2012
- Review
- 414 days
- Class
- Class II
- Product code
- DXX
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 8 generations to K900765 (1990). 14 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 7 generations backK013484 Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital…Stereotaxis, Inc. · 2002
- 6 generations backK021555 Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003
- 5 generations backK052480 Hansen Medical Catheter Control System (CCS) and Accessories, Hansen…Hansen Medical, Inc. · 2007 · Recalled
- 4 generations backK073225 Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · Recalled
- 3 generations backK090365 Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · Recalled
- 2 generations backK091808 Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc. · 2009 · Recalled
- 1 generation backK102168 Sensei X Robotic Catheter SystemHansen Medical, Inc. · 2010 · Recalled
- This deviceK111004 Hansen Medical Vascular Catheter Control System and CatheterHansen Medical, Inc. · 2012
- Descendant · cites it directly · 9 of its ownK132369 Magellan Robotic System, Magellan Robotic Catheter 9FRHansen Medical, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 5 of its ownK141614 Magellan Robotic SystemHansen Medical · 2014 · Recalled
- Descendant · cites it directly · 2 of its ownK152999 CorPath 200 SystemCorindus, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK133552 Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic…Hansen Medical · 2014
- Descendant · 2 generations on · 1 of its ownK173288 CorPath GRX SystemCorindus, Inc. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K132369Magellan Robotic System, Magellan Robotic Catheter 9FRHansen Medical, Inc. · 2013 · cites it directly9descendants
- K141614Magellan Robotic SystemHansen Medical · 2014 · 2 generations on5descendants
- K152999CorPath 200 SystemCorindus, Inc. · 2016 · cites it directly2descendants
- K133552Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic Catheter 6FR…Hansen Medical · 2014 · 2 generations on2descendants
- K173288CorPath GRX SystemCorindus, Inc. · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K900765 | Steerocath (TM) | Ep Technologies, Inc. | 1990 | — |
| −7 | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging… | Stereotaxis, Inc. | 2002 | — |
| −6 | K021555 | Stereotaxis Niobe Magnetic Navigation System | Stereotaxis, Inc. | 2003 | — |
| −5 | K052480 | Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical… | Hansen Medical, Inc. | 2007 | 2 |
| −4 | K073225 | Sensei Catheter Control System | Hansen Medical, Inc. | 2008 | 1 |
| −3 | K090365 | Hansen Medical Artisan S Control Catheter | Hansen Medical, Inc. | 2009 | 1 |
| −2 | K091808 | Sensei Robotic Catheter System, Model 02057 | Hansen Medical, Inc. | 2009 | 1 |
| −1 | K102168 | Sensei X Robotic Catheter System | Hansen Medical, Inc. | 2010 | 1 |
| 0 (this device) | K111004 | Hansen Medical Vascular Catheter Control System and Catheter | Hansen Medical, Inc. | 2012 | — |
| +1 | K132369 | Magellan Robotic System, Magellan Robotic Catheter 9FR | Hansen Medical, Inc. | 2013 | 2 |
| +2 | K141614 | Magellan Robotic System | Hansen Medical | 2014 | 2 |
| +1 | K152999 | CorPath 200 System | Corindus, Inc. | 2016 | — |
| +2 | K133552 | Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic Catheter… | Hansen Medical | 2014 | — |
| +2 | K173288 | CorPath GRX System | Corindus, Inc. | 2018 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K080415 | Device Modification to Pinnacle Destination Peripheral Guiding SheathSummary page 1…The Hansen Medical Magellan Robotic System, including the NorthStar Robotic Catheter, is substantially equivalent to: * Terumo Pinnacle Destination System (K080415) * Hansen Medical Sensei® X Catheter Control System and Artisan Control Catheter (K1 02168)… | 2008 |
| * | K102168 | Sensei X Robotic Catheter SystemSummary page 1…ially equivalent to: * Terumo Pinnacle Destination System (K080415) * Hansen Medical Sensei® X Catheter Control System and Artisan Control Catheter (K1 02168) Page 15-1 Attachment 15-I1:… | 2010 |
What descends from it? (10)
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 22 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 14 ancestors have a recall of any class.
- Of its descendants, K132369 (Hansen Medical, Inc., 2013) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K080415.
How does its category compare?
All DXX devicesDXX System, Catheter Control, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Hansen Medical Vascular Catheter Control System, Hansen Catheter 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111004 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111004: Hansen Medical Vascular Catheter Control System and Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111004
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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