510(k) · Cleared
ClearedCorpath 200 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corindus, Inc. · DXX System, Catheter Control, Steerable
Cleared on Jul 19, 2012 as substantially equivalent to K060967 (Stereotaxis, Inc., 2006) and 1 other predicate after a 122-day review. Its family tree reaches back 7 generations to 1990. 8 later devices descend from it.
- Decided
- Jul 19, 2012
- Review
- 122 days
- Class
- Class II
- Product code
- DXX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K900765 (1990). 10 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 6 generations backK013484 Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital…Stereotaxis, Inc. · 2002
- 5 generations backK021555 Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003
- 4 generations backK052480 Hansen Medical Catheter Control System (CCS) and Accessories, Hansen…Hansen Medical, Inc. · 2007 · Recalled
- 3 generations backK073225 Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · Recalled
- 2 generations backK090365 Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · Recalled
- 1 generation backK091808 Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc. · 2009 · Recalled
- This deviceK120834 Corpath 200 SystemCorindus, Inc. · 2012
- Descendant · cites it directly · 7 of its ownK150892 CorPath 200 SystemCorindus, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK160121 CorPath GRX SystemCorindus, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK173806 CorPath GRX SystemCorindus, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK152999 CorPath 200 SystemCorindus, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK202275 CorPath GRX SystemCorindus, Inc. · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K150892CorPath 200 SystemCorindus, Inc. · 2015 · cites it directly7descendants
- K160121CorPath GRX SystemCorindus, Inc. · 2016 · cites it directly5descendants
- K173806CorPath GRX SystemCorindus, Inc. · 2018 · 2 generations on2descendants
- K152999CorPath 200 SystemCorindus, Inc. · 2016 · cites it directly2descendants
- K202275CorPath GRX SystemCorindus, Inc. · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K900765 | Steerocath (TM) | Ep Technologies, Inc. | 1990 | — |
| −6 | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging… | Stereotaxis, Inc. | 2002 | — |
| −5 | K021555 | Stereotaxis Niobe Magnetic Navigation System | Stereotaxis, Inc. | 2003 | — |
| −4 | K052480 | Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical… | Hansen Medical, Inc. | 2007 | 2 |
| −3 | K073225 | Sensei Catheter Control System | Hansen Medical, Inc. | 2008 | 1 |
| −2 | K090365 | Hansen Medical Artisan S Control Catheter | Hansen Medical, Inc. | 2009 | 1 |
| −1 | K091808 | Sensei Robotic Catheter System, Model 02057 | Hansen Medical, Inc. | 2009 | 1 |
| 0 (this device) | K120834 | Corpath 200 System | Corindus, Inc. | 2012 | — |
| +1 | K150892 | CorPath 200 System | Corindus, Inc. | 2015 | — |
| +1 | K160121 | CorPath GRX System | Corindus, Inc. | 2016 | — |
| +2 | K173806 | CorPath GRX System | Corindus, Inc. | 2018 | — |
| +1 | K152999 | CorPath 200 System | Corindus, Inc. | 2016 | — |
| +3 | K202275 | CorPath GRX System | Corindus, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K060967 | Niobe Magnetic Navigation System W/Navigant WorkstationSummary page 1…control system) Regulation Number: 21 CFR 870.1290 (Steerable catheter control system) Predicate Device(s): 1. Niobe® MNS w/Navigant TM Navigation Workstation (K060967) 2. Sensei® Robotic Catheter System (K09 1808) Summary of Comparison of the CorPath 200 System t… | 2006 |
| * | K091808 | Sensei Robotic Catheter System, Model 02057Summary page 1…70.1290 (Steerable catheter control system) Predicate Device(s): 1. Niobe® MNS w/Navigant TM Navigation Workstation (K060967) 2. Sensei® Robotic Catheter System (K09 1808) Summary of Comparison of the CorPath 200 System to Predicate Devices Device Name CorPath… | 2009 |
What descends from it? (8)
3 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)
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 1.2 years on median.
- 5 of the 10 ancestors have a recall of any class.
- Of its descendants, K150892 (Corindus, Inc., 2015) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K060967.
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 CorPath 200 System is intended for use in the remote delivery and manipulation of coronary guidewires and balloon/stent catheters during percutaneous coronary intervention (PCI) procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120834 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120834: Corpath 200 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120834
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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