510(k) · Decided
Recalled · Class II · 2014Sensei Robotic Catheter System, Model 02057
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 10, 2009 as substantially equivalent to K090365 (Hansen Medical, Inc., 2009) after an 84-day review. Its family tree reaches back 6 generations to 1990. 19 later devices descend from it. It has been recalled once.
- Decided
- Sep 10, 2009
- Review
- 84 days
- Class
- Class II
- Product code
- DXX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K900765 (1990). 8 ancestors in all. 19 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 5 generations backK013484 Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital…Stereotaxis, Inc. · 2002
- 4 generations backK021555 Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003
- 3 generations backK052480 Hansen Medical Catheter Control System (CCS) and Accessories, Hansen…Hansen Medical, Inc. · 2007 · Recalled
- 2 generations backK073225 Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · Recalled
- 1 generation backK090365 Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · Recalled
- This deviceK091808 Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc. · 2009
- Descendant · cites it directly · 12 of its ownK102168 Sensei X Robotic Catheter SystemHansen Medical, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 10 of its ownK111004 Hansen Medical Vascular Catheter Control System and CatheterHansen Medical, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 9 of its ownK132369 Magellan Robotic System, Magellan Robotic Catheter 9FRHansen Medical, Inc. · 2013 · Recalled
- Descendant · cites it directly · 8 of its ownK120834 Corpath 200 SystemCorindus, Inc. · 2012
- Descendant · 2 generations on · 7 of its ownK150892 CorPath 200 SystemCorindus, Inc. · 2015
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K102168Sensei X Robotic Catheter SystemHansen Medical, Inc. · 2010 · cites it directly12descendants
- K111004Hansen Medical Vascular Catheter Control System and CatheterHansen Medical, Inc. · 2012 · 2 generations on10descendants
- K132369Magellan Robotic System, Magellan Robotic Catheter 9FRHansen Medical, Inc. · 2013 · 3 generations on9descendants
- K120834Corpath 200 SystemCorindus, Inc. · 2012 · cites it directly8descendants
- K150892CorPath 200 SystemCorindus, Inc. · 2015 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K900765 | Steerocath (TM) | Ep Technologies, Inc. | 1990 | — |
| −5 | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging… | Stereotaxis, Inc. | 2002 | — |
| −4 | K021555 | Stereotaxis Niobe Magnetic Navigation System | Stereotaxis, Inc. | 2003 | — |
| −3 | K052480 | Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical… | Hansen Medical, Inc. | 2007 | 2 |
| −2 | K073225 | Sensei Catheter Control System | Hansen Medical, Inc. | 2008 | 1 |
| −1 | K090365 | Hansen Medical Artisan S Control Catheter | Hansen Medical, Inc. | 2009 | 1 |
| 0 (this device) | K091808 | Sensei Robotic Catheter System, Model 02057 | Hansen Medical, Inc. | 2009 | — |
| +1 | K102168 | Sensei X Robotic Catheter System | Hansen Medical, Inc. | 2010 | 1 |
| +2 | 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 |
| +1 | K120834 | Corpath 200 System | Corindus, Inc. | 2012 | — |
| +2 | K150892 | CorPath 200 System | Corindus, Inc. | 2015 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 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 |
|---|---|---|---|
| * | K090365 | Hansen Medical Artisan S Control CatheterSummary page 1…earlier substantially equivalent, in intended use and method of operation to the Sensei System (K090365). Device Description: when The Hansen… | 2009 |
What descends from it? (19)
See all 192 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K102168 (Hansen Medical, Inc., 2010) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K090365.
How does its category compare?
All DXX devicesDXX System, Catheter Control, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Sensei® Robotic Catheter System and Accessories are intended to facilitate manipulation, positioning and control of Hansen Medical's robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx™ Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091808 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091808: Sensei Robotic Catheter System, Model 02057.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091808
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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