510(k) · Cleared
ClearedAmigo Remote Catheter System (RCS) & Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Catheter Robotics, Inc. · DXX System, Catheter Control, Steerable
Cleared on Jun 12, 2012 as substantially equivalent to K052480 (Hansen Medical, Inc., 2007) and 1 other predicate after a 187-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it.
- Decided
- Jun 12, 2012
- Review
- 187 days
- Class
- Class II
- Product code
- DXX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K900765 (1990). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 3 generations backK013484 Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital…Stereotaxis, Inc. · 2002
- 2 generations backK021555 Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003
- 1 generation backK052480 Hansen Medical Catheter Control System (CCS) and Accessories, Hansen…Hansen Medical, Inc. · 2007 · Recalled
- This deviceK113628 Amigo Remote Catheter System (RCS) & AccessoriesCatheter Robotics, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK122488 Amigo Remote Catheter System & AccessoriesCatheter Robotics, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K122488Amigo Remote Catheter System & AccessoriesCatheter Robotics, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K900765 | Steerocath (TM) | Ep Technologies, Inc. | 1990 | — |
| −3 | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging… | Stereotaxis, Inc. | 2002 | — |
| −2 | K021555 | Stereotaxis Niobe Magnetic Navigation System | Stereotaxis, Inc. | 2003 | — |
| −1 | K052480 | Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical… | Hansen Medical, Inc. | 2007 | 2 |
| 0 (this device) | K113628 | Amigo Remote Catheter System (RCS) & Accessories | Catheter Robotics, Inc. | 2012 | — |
| +1 | K122488 | Amigo Remote Catheter System & Accessories | Catheter Robotics, Inc. | 2012 | — |
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 |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K052480 | Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical Steerable…Summary page 1…0, Product Code DXX) Predicate Devices: .Hansen Medical Catheter Control System (CCS) & Accessories, Hansen Medical, Inc. (K052480) Stereotaxis Niobe MNS Catheter Control System & Accessories,… | 2007 |
| * | K021555 | Stereotaxis Niobe Magnetic Navigation SystemSummary page 1…edical, Inc. (K052480) Stereotaxis Niobe MNS Catheter Control System & Accessories, Stereotaxis, Inc. (K021555) Manufacturer: Catheter Robotics, Inc. 500 International Drive… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122488 | Amigo Remote Catheter System & Accessories | 2012 | 0 |
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 22 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K122488 (Catheter Robotics, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K052480.
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 Amigo Remote Catheter System (ROS) is intended to facilitate manipulation, positioning and control of percutaneous diagnostic catheters for stimulating cardiac tissue and for recording electrophysiological data in the right atrium and right ventricle.
The safety and effectiveness of this device for ablation in the treatment of cardiac arrhythmias including atrial fibrillation, has not been established.
The safety and effectiveness of this device for cardiac mapping when used with any catheter other than the Boston Scientific BlazerTm Dx-20 has not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113628: Amigo Remote Catheter System (RCS) & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113628
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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