510(k) · Cleared
ClearedCarto XP EP Navigation System, Version 10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosense Webster, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Jun 18, 2010 as substantially equivalent to K070240 (Biosense Webster, Inc., 2007) and 1 other predicate after a 212-day review. Its family tree reaches back 7 generations to 2000. 14 later devices descend from it.
- Decided
- Jun 18, 2010
- Review
- 212 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K001437 (2000). 15 ancestors in all, the oldest K982415 (1998). 14 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 6 generations backK012926 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2001
- 5 generations backK030129 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2003
- 4 generations backK042493 Ensite System, Model EE3000Endocardial Solutions, Inc. · 2004
- 3 generations backK060954 Modification to Ensite System, Model EE3000St. Jude Medical, Inc.-Endocardial Solutions · 2006
- 2 generations backK072202 Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External…Biosense Webster, Inc. · 2007
- 1 generation backK090017 Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- This deviceK093566 Carto XP EP Navigation System, Version 10Biosense Webster, Inc. · 2010
- Descendant · cites it directly · 8 of its ownK201298 VX1Volta Medical · 2020
- Descendant · 2 generations on · 4 of its ownK223516 VX1+Volta Medical · 2023
- Descendant · cites it directly · 4 of its ownK132782 CARTO3 EP Navigation System, Version 3.2Biosense Webster, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 3 of its ownK162793 RHYTHMIA HDx Mapping SystemBoston Scientific Corporation · 2017
- Descendant · 2 generations on · 2 of its ownK232616 Volta AF-XplorerVolta Medical · 2023
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K201298VX1Volta Medical · 2020 · cites it directly8descendants
- K223516VX1+Volta Medical · 2023 · 2 generations on4descendants
- K132782CARTO3 EP Navigation System, Version 3.2Biosense Webster, Inc. · 2014 · cites it directly4descendants
- K162793RHYTHMIA HDx Mapping SystemBoston Scientific Corporation · 2017 · 2 generations on3descendants
- K232616Volta AF-XplorerVolta Medical · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001437 | Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2000 | — |
| −6 | K012926 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2001 | — |
| −5 | K030129 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2003 | — |
| −4 | K042493 | Ensite System, Model EE3000 | Endocardial Solutions, Inc. | 2004 | — |
| −3 | K060954 | Modification to Ensite System, Model EE3000 | St. Jude Medical, Inc.-Endocardial Solutions | 2006 | — |
| −2 | K072202 | Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference… | Biosense Webster, Inc. | 2007 | — |
| −1 | K090017 | Carto 3 EP Navigation System, V1.0 and Accessories | Biosense Webster, Inc. | 2009 | 4 |
| 0 (this device) | K093566 | Carto XP EP Navigation System, Version 10 | Biosense Webster, Inc. | 2010 | — |
| +1 | K201298 | VX1 | Volta Medical | 2020 | — |
| +2 | K223516 | VX1+ | Volta Medical | 2023 | — |
| +1 | K132782 | CARTO3 EP Navigation System, Version 3.2 | Biosense Webster, Inc. | 2014 | 1 |
| +2 | K162793 | RHYTHMIA HDx Mapping System | Boston Scientific Corporation | 2017 | — |
| +2 | K232616 | Volta AF-Xplorer | Volta Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 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 |
|---|---|---|---|
| * | K070240 | Carto XP EP Navigation System, Version 9Summary page 1…ode DQK) Predicate Devices: 1. CARTO® XP EP Navigation System, Version 9 5 10O(k) K070240 2. CARTro® 3 EP Navigation System, Version… | 2007 |
| * | K090017 | Carto 3 EP Navigation System, V1.0 and AccessoriesSummary page 1…070240 2. CARTro® 3 EP Navigation System, Version 1.0 5l0 (k) K090017 Manufacturer: Biosense Webster (Israel) Ltd.… | 2009 |
What descends from it? (14)
See all 142 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 10 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K201298 (Volta Medical, 2020) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K070240.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The intended use of the CARTO® XP System With CARTOXPRESSTM Module (V10) is catheter-based atrial and ventricular mapping. The CARTO® XP System With CARTOXPRESSTM Module (V10) allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, and cardiac chamber geometry maps. The acquired patient…
Read the full statement (188 words)
The intended use of the CARTO® XP System With CARTOXPRESSTM Module (V10) is catheter-based atrial and ventricular mapping.
The CARTO® XP System With CARTOXPRESSTM Module (V10) allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real-time on the system display screen.
CARTO XP System with CARTOXPRESSTM Module (V10) includes the CARTOMERGE® capability to import, register, and merge CT or MRI structural images with CARTO Maps physiological information and real-time catheter navigation. CARTO® XP System with CARTOXPRESSTM Module (V10) also allows the integration of intracardiac echo (ICE) 2D images to provide 3D combined maps.
CARTO® XP System with CARTOXPRESSTM Module (V10) includes Fast Anatomical Mapping (FAM) that is a method for quick creation of cardiac anatomical volumes using catheters with magnetic location sensors, supports the LASSO® NAV Catheter with location sensors, displays Complex Fractionated Atrial Electrograms (CFAE), and adds Pace-Mapping Software (PaSo) ECG signal correlation tool.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093566 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093566: Carto XP EP Navigation System, Version 10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093566
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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