510(k) · Cleared
Recalled · Class II · 2016Carto 3 EP Navigation System, Version 2.2
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 Oct 5, 2011 as substantially equivalent to K103746 (Biosense Webster, Inc., 2011) after an 83-day review. Its family tree reaches back 9 generations to 2000. 32 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 5, 2011
- Review
- 83 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 9 generations to K001437 (2000). 19 ancestors in all, the oldest K982415 (1998). 32 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 5 generations between
- 3 generations backK090017 Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- 2 generations backK093455 Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- 1 generation backK103746 Carto 3 EP Navigation System, Version 2.0 (W/Standard Location…Biosense Webster, Inc. · 2011 · Recalled
- This deviceK112007 Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011
- Descendant · cites it directly · 31 of its ownK120550 Carto (R) EP Navigation System, Version 3.0 (with Standard Location…Biosense Webster, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 27 of its ownK133916 Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 20 of its ownK170600 CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc. · 2017
- Descendant · 4 generations on · 19 of its ownK180238 CARTO 3 EP Navigation System, Version 6.0 and Accessories with…Biosense Webster, Inc. · 2018
- Descendant · 5 generations on · 16 of its ownK191660 CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc. · 2019 · Recalled
Show all 9 generations
- Root · 9 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 8 generations backK012926 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2001
- 7 generations backK030129 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2003
- 6 generations backK042493 Ensite System, Model EE3000Endocardial Solutions, Inc. · 2004
- 5 generations backK060954 Modification to Ensite System, Model EE3000St. Jude Medical, Inc.-Endocardial Solutions · 2006
- 4 generations backK072202 Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External…Biosense Webster, Inc. · 2007
- 3 generations backK090017 Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- 2 generations backK093455 Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- 1 generation backK103746 Carto 3 EP Navigation System, Version 2.0 (W/Standard Location…Biosense Webster, Inc. · 2011 · Recalled
- This deviceK112007 Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K120550Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad)Biosense Webster, Inc. · 2012 · cites it directly31descendants
- K133916Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc. · 2014 · 2 generations on27descendants
- K170600CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc. · 2017 · 3 generations on20descendants
- K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINTBiosense Webster, Inc. · 2018 · 4 generations on19descendants
- K191660CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc. · 2019 · 5 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001437 | Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2000 | — |
| −8 | K012926 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2001 | — |
| −7 | K030129 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2003 | — |
| −6 | K042493 | Ensite System, Model EE3000 | Endocardial Solutions, Inc. | 2004 | — |
| −5 | K060954 | Modification to Ensite System, Model EE3000 | St. Jude Medical, Inc.-Endocardial Solutions | 2006 | — |
| −4 | K072202 | Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference… | Biosense Webster, Inc. | 2007 | — |
| −3 | K090017 | Carto 3 EP Navigation System, V1.0 and Accessories | Biosense Webster, Inc. | 2009 | 4 |
| −2 | K093455 | Carto 3 Version 1.05 EP Navigation System and Accessories | Biosense Webster, Inc. | 2009 | 1 |
| −1 | K103746 | Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3… | Biosense Webster, Inc. | 2011 | 1 |
| 0 (this device) | K112007 | Carto 3 EP Navigation System, Version 2.2 | Biosense Webster, Inc. | 2011 | — |
| +1 | K120550 | Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad) | Biosense Webster, Inc. | 2012 | 2 |
| +2 | K133916 | Carto 3 EP Navigation System, Version 4.2 | Biosense Webster, Inc. | 2014 | 2 |
| +3 | K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | Biosense Webster, Inc. | 2017 | — |
| +4 | K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | Biosense Webster, Inc. | 2018 | — |
| +5 | K191660 | CARTO 3 EP Navigation System, Version 7.1 and Accessories | Biosense Webster, Inc. | 2019 | 1 |
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 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K103746 | Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation…Summary page 1…11, 21 CFR 870.1425 Product Code DQK Predicate Device: CARTO® 3 V2.0 EP Navigation System and Accessories 5 10(k) K103 746, January 21, 2011 Manufacturing Facility: Biosense Webster (Israel) Ltd. 4 Hatnu… | 2011 |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120550 | Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad) | 2012 | 31 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 15, 2016 | Class II | Z-2776-2016 | Under Investigation by firm | Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the… |
| Feb 9, 2012 | Not classified | Z-1230-2012 | Nonconforming Material/Component | Some CARTO 3 Systems may get radio frequency interference through certain interconnected cable configurations resulting in jumping or disappearing catheter icon and/or error messages during ablation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K120550 (Biosense Webster, Inc., 2012) has gone furthest, with 31 descendants of its own.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 CARTO® 3 V2.2 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface…
Read the full statement (226 words)
The CARTO® 3 V2.2 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be displayed in real time on the system's display screen. The CARTO® 3 V2.2 System is also intended to support EP procedures, maintaining CARTO® System capabilities in the presence of a high metallic environment and magnetic field strengths up to 0. 1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V2.2 System includes CARTOMERGE®'PLUS functionality to import, register and merge CT or MRI structural images with CARTO®(map'Is physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUNO image integration functionality enables integration of intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, non-navigational, eleetrophysiology catheters without magnetic location sensors.
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/K112007 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112007: Carto 3 EP Navigation System, Version 2.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112007
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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