510(k) · Decided
Recalled · Class II · 2014Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical Steerable Guide Catheter (SGC) and Sheath
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 2, 2007 as substantially equivalent to K021555 (Stereotaxis, Inc., 2003) after a 600-day review. Its family tree reaches back 3 generations to 1990. 27 later devices descend from it. It has been recalled 2 times.
- Decided
- May 2, 2007
- Review
- 600 days
- Class
- Class II
- Product code
- DXX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K900765 (1990). 5 ancestors in all. 27 later devices descend from it, 2 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 deviceK052480 Hansen Medical Catheter Control System (CCS) and Accessories, Hansen…Hansen Medical, Inc. · 2007
- Descendant · cites it directly · 24 of its ownK073225 Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 22 of its ownK090365 Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 19 of its ownK091808 Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 12 of its ownK102168 Sensei X Robotic Catheter SystemHansen Medical, Inc. · 2010 · Recalled
- Descendant · 5 generations on · 10 of its ownK111004 Hansen Medical Vascular Catheter Control System and CatheterHansen Medical, Inc. · 2012 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K073225Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · cites it directly24descendants
- K090365Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · 2 generations on22descendants
- K091808Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc. · 2009 · 3 generations on19descendants
- K102168Sensei X Robotic Catheter SystemHansen Medical, Inc. · 2010 · 4 generations on12descendants
- K111004Hansen Medical Vascular Catheter Control System and CatheterHansen Medical, Inc. · 2012 · 5 generations on10descendants
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) | K052480 | Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical… | Hansen Medical, Inc. | 2007 | — |
| +1 | K073225 | Sensei Catheter Control System | Hansen Medical, Inc. | 2008 | 1 |
| +2 | 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 |
| +4 | K102168 | Sensei X Robotic Catheter System | Hansen Medical, Inc. | 2010 | 1 |
| +5 | K111004 | Hansen Medical Vascular Catheter Control System and Catheter | Hansen Medical, Inc. | 2012 | 2 |
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 |
|---|---|---|
| 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 |
| 2020 | 1 | 0 |
| 2022 | 1 | 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 |
|---|---|---|---|
| * | K021555 | Stereotaxis Niobe Magnetic Navigation SystemSummary page 1…rable Guide Catheter and Sheath are substantially equivalent inintended use and method of operation to: Stereotaxis Niobe Magnetic Navigation System Stereotaxis, Inc. - K021555 Hansen Medical 510(k) Submission Section 6, Page 1 of 2 CCS and SGC… | 2003 |
What descends from it? (27)
See all 272 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 |
|---|---|---|---|---|
| Dec 4, 2014 | Class II | Z-0896-2015 | Device Design | The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to the operating table with the potential for the device to fall causing, uncontrolled catheter movement. cardiac tampenade, delayed procedure… |
| May 21, 2008 | Not classified | Z-2106-2008 | Device Design | The catheter's flexible bellows portion may develop a leak. This has the potential to cause loss of hemostasis, flush fluid leakage, and/or introduction of air into the catheter with a risk of subsequent embolism. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K073225 (Hansen Medical, Inc., 2008) has gone furthest, with 24 descendants of its own.
- 3 other devices also cite its predicate K021555.
How does its category compare?
All DXX devicesDXX System, Catheter Control, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Catheter Control System, Steerable Guide Catheter, Sheath, and accessories are intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-DxTM Steerable Diagnostic catheters made by Boston Scientific Corporation and the LivewireTM Electrophysiology catheters made by St. Jude Medical.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052480: Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical Steerable Guide Catheter (SGC) and Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052480
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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