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 Oct 27, 2016 as substantially equivalent to K120834 (Corindus, Inc., 2012) and 1 other predicate after a 282-day review. Its family tree reaches back 9 generations to 1990. 5 later devices descend from it.
- Decided
- Oct 27, 2016
- Review
- 282 days
- Class
- Class II
- Product code
- DXX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K900765 (1990). 12 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 5 generations between
- 3 generations backK091808 Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc. · 2009 · Recalled
- 2 generations backK120834 Corpath 200 SystemCorindus, Inc. · 2012
- 1 generation backK150892 CorPath 200 SystemCorindus, Inc. · 2015
- This deviceK160121 CorPath GRX SystemCorindus, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK173806 CorPath GRX SystemCorindus, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK202275 CorPath GRX SystemCorindus, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK173288 CorPath GRX SystemCorindus, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK221464 CorPath GRX SystemCorindus, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK180517 CorPath GRX SystemCorindus, Inc. · 2018
Show all 9 generations
- Root · 9 generations backK900765 Steerocath (TM)Ep Technologies, Inc. · 1990
- 8 generations backK013484 Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital…Stereotaxis, Inc. · 2002
- 7 generations backK021555 Stereotaxis Niobe Magnetic Navigation SystemStereotaxis, Inc. · 2003
- 6 generations backK052480 Hansen Medical Catheter Control System (CCS) and Accessories, Hansen…Hansen Medical, Inc. · 2007 · Recalled
- 5 generations backK073225 Sensei Catheter Control SystemHansen Medical, Inc. · 2008 · Recalled
- 4 generations backK090365 Hansen Medical Artisan S Control CatheterHansen Medical, Inc. · 2009 · Recalled
- 3 generations backK091808 Sensei Robotic Catheter System, Model 02057Hansen Medical, Inc. · 2009 · Recalled
- 2 generations backK120834 Corpath 200 SystemCorindus, Inc. · 2012
- 1 generation backK150892 CorPath 200 SystemCorindus, Inc. · 2015
- This deviceK160121 CorPath GRX SystemCorindus, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K173806CorPath GRX SystemCorindus, Inc. · 2018 · cites it directly2descendants
- K202275CorPath GRX SystemCorindus, Inc. · 2020 · 2 generations on1descendant
- K173288CorPath GRX SystemCorindus, Inc. · 2018 · cites it directly1descendant
- K221464CorPath GRX SystemCorindus, Inc. · 2022 · 3 generations on0descendants
- K180517CorPath GRX SystemCorindus, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K900765 | Steerocath (TM) | Ep Technologies, Inc. | 1990 | — |
| −8 | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging… | Stereotaxis, Inc. | 2002 | — |
| −7 | K021555 | Stereotaxis Niobe Magnetic Navigation System | Stereotaxis, Inc. | 2003 | — |
| −6 | K052480 | Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical… | Hansen Medical, Inc. | 2007 | 2 |
| −5 | K073225 | Sensei Catheter Control System | Hansen Medical, Inc. | 2008 | 1 |
| −4 | 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 |
| −2 | K120834 | Corpath 200 System | Corindus, Inc. | 2012 | — |
| −1 | K150892 | CorPath 200 System | Corindus, Inc. | 2015 | — |
| 0 (this device) | K160121 | CorPath GRX System | Corindus, Inc. | 2016 | — |
| +1 | K173806 | CorPath GRX System | Corindus, Inc. | 2018 | — |
| +2 | K202275 | CorPath GRX System | Corindus, Inc. | 2020 | — |
| +1 | K173288 | CorPath GRX System | Corindus, Inc. | 2018 | — |
| +3 | K221464 | CorPath GRX System | Corindus, Inc. | 2022 | — |
| +2 | K180517 | CorPath GRX System | Corindus, Inc. | 2018 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K120834 | Corpath 200 SystemSummary page 4…catheter control system) Classification Name: Steerable Catheter Control System 3. PREDICATE DEVICE • CorPath 200 System manufactured by Corindus, Inc., K120834 and K150892. 4. DEVICE DESCRIPTION The CorPath GRX System is intended to allow physicians to deliver and manipulate commer… | 2012 |
| * | K150892 | CorPath 200 SystemSummary page 4…ntrol system) Classification Name: Steerable Catheter Control System 3. PREDICATE DEVICE • CorPath 200 System manufactured by Corindus, Inc., K120834 and K150892. 4. DEVICE DESCRIPTION The CorPath GRX System is intended to allow physicians to deliver and manipulate commercially avail… | 2015 |
What descends from it? (5)
2 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 26 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 12 ancestors have a recall of any class.
- Of its descendants, K173806 (Corindus, Inc., 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K120834.
How does its category compare?
All DXX devicesDXX System, Catheter Control, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160121: CorPath GRX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160121
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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