510(k) · Cleared
ClearedCorPath GRX 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 27, 2022 as substantially equivalent to K202275 (Corindus, Inc., 2020) after a 69-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- Jul 27, 2022
- Review
- 69 days
- Class
- Class II
- Product code
- DXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K900765 (1990). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 8 generations between
- 3 generations backK160121 CorPath GRX SystemCorindus, Inc. · 2016
- 2 generations backK173806 CorPath GRX SystemCorindus, Inc. · 2018
- 1 generation backK202275 CorPath GRX SystemCorindus, Inc. · 2020
- This deviceK221464 CorPath GRX SystemCorindus, Inc. · 2022
Show all 12 generations
- Root · 12 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 11 generations backK013484 Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital…Stereotaxis, Inc. · 2002
- 10 generations backK021555 Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003
- 9 generations backK052480 Hansen Medical Catheter Control System (CCS) and Accessories, Hansen…Hansen Medical, Inc. · 2007 · Recalled
- 8 generations backK073225 Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · Recalled
- 7 generations backK090365 Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · Recalled
- 6 generations backK091808 Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc. · 2009 · Recalled
- 5 generations backK120834 Corpath 200 SystemCorindus, Inc. · 2012
- 4 generations backK150892 CorPath 200 SystemCorindus, Inc. · 2015
- 3 generations backK160121 CorPath GRX SystemCorindus, Inc. · 2016
- 2 generations backK173806 CorPath GRX SystemCorindus, Inc. · 2018
- 1 generation backK202275 CorPath GRX SystemCorindus, Inc. · 2020
- This deviceK221464 CorPath GRX SystemCorindus, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K900765 | Steerocath (TM) | Ep Technologies, Inc. | 1990 | — |
| −11 | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging… | Stereotaxis, Inc. | 2002 | — |
| −10 | K021555 | Stereotaxis Niobe Magnetic Navigation System | Stereotaxis, Inc. | 2003 | — |
| −9 | K052480 | Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical… | Hansen Medical, Inc. | 2007 | 2 |
| −8 | K073225 | Sensei Catheter Control System | Hansen Medical, Inc. | 2008 | 1 |
| −7 | K090365 | Hansen Medical Artisan S Control Catheter | Hansen Medical, Inc. | 2009 | 1 |
| −6 | K091808 | Sensei Robotic Catheter System, Model 02057 | Hansen Medical, Inc. | 2009 | 1 |
| −5 | K120834 | Corpath 200 System | Corindus, Inc. | 2012 | — |
| −4 | K150892 | CorPath 200 System | Corindus, Inc. | 2015 | — |
| −3 | K160121 | CorPath GRX System | Corindus, Inc. | 2016 | — |
| −2 | K173806 | CorPath GRX System | Corindus, Inc. | 2018 | — |
| −1 | K202275 | CorPath GRX System | Corindus, Inc. | 2020 | — |
| 0 (this device) | K221464 | CorPath GRX System | Corindus, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K202275 | CorPath GRX SystemSummary page 4…ss: II Device (Predicate Product Code: DXX Device): Regulation Number: 21 CFR 870.1290 510(k) Number: K202275 Device Description: The CorPath GRX System is intended to allow physicians to deliver and manip… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 15 ancestors have a recall of any class.
How does its category compare?
All DXX devicesDXX System, Catheter Control, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221464 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221464: CorPath GRX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221464
Report an extraction error
Are you the manufacturer?
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