510(k) · Cleared
Recalled · Class II · 2012Carto 3 EP Navigation System, V1.0 and Accessories
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 13, 2009 as substantially equivalent to K072202 (Biosense Webster, Inc., 2007) and 2 other predicates after a 284-day review. Its family tree reaches back 6 generations to 2000. 45 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 13, 2009
- Review
- 284 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 6 generations to K001437 (2000). 14 ancestors in all, the oldest K982415 (1998). 45 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 5 generations backK012926 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2001
- 4 generations backK030129 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2003
- 3 generations backK042493 Ensite System, Model EE3000Endocardial Solutions, Inc. · 2004
- 2 generations backK060954 Modification to Ensite System, Model EE3000St. Jude Medical, Inc.-Endocardial Solutions · 2006
- 1 generation backK072202 Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External…Biosense Webster, Inc. · 2007
- This deviceK090017 Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009
- Descendant · cites it directly · 34 of its ownK093455 Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 33 of its ownK103746 Carto 3 EP Navigation System, Version 2.0 (W/Standard Location…Biosense Webster, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 32 of its ownK112007 Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 31 of its ownK120550 Carto (R) EP Navigation System, Version 3.0 (with Standard Location…Biosense Webster, Inc. · 2012 · Recalled
- Descendant · 5 generations on · 27 of its ownK133916 Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc. · 2014 · Recalled
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K093455Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc. · 2009 · cites it directly34descendants
- K103746Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation…Biosense Webster, Inc. · 2011 · 2 generations on33descendants
- K112007Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011 · 3 generations on32descendants
- K120550Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad)Biosense Webster, Inc. · 2012 · 4 generations on31descendants
- K133916Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc. · 2014 · 5 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001437 | Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2000 | — |
| −5 | K012926 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2001 | — |
| −4 | K030129 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2003 | — |
| −3 | K042493 | Ensite System, Model EE3000 | Endocardial Solutions, Inc. | 2004 | — |
| −2 | K060954 | Modification to Ensite System, Model EE3000 | St. Jude Medical, Inc.-Endocardial Solutions | 2006 | — |
| −1 | K072202 | Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference… | Biosense Webster, Inc. | 2007 | — |
| 0 (this device) | K090017 | Carto 3 EP Navigation System, V1.0 and Accessories | Biosense Webster, Inc. | 2009 | — |
| +1 | K093455 | Carto 3 Version 1.05 EP Navigation System and Accessories | Biosense Webster, Inc. | 2009 | 1 |
| +2 | K103746 | Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3… | Biosense Webster, Inc. | 2011 | 1 |
| +3 | K112007 | Carto 3 EP Navigation System, Version 2.2 | Biosense Webster, Inc. | 2011 | 2 |
| +4 | K120550 | Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad) | Biosense Webster, Inc. | 2012 | 2 |
| +5 | K133916 | Carto 3 EP Navigation System, Version 4.2 | Biosense Webster, Inc. | 2014 | 2 |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 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 26.6 · 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? (3)
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 |
|---|---|---|---|
| * | K072202 | Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches…Summary page 1…ogrammable diagnostic computer (per 21 CFR 870.1425, Product Code DQK) Predicate Device: CARTO III EP Navigation System (K072202) CARTO RMT V8 EP Navigation System (K060047) CARTO V9 XP EP Nav… | 2007 |
| * | K060047 | Carto RMT EP Navigation System V8Summary page 1…70.1425, Product Code DQK) Predicate Device: CARTO III EP Navigation System (K072202) CARTO RMT V8 EP Navigation System (K060047) CARTO V9 XP EP Navigation System (K070240) Manufacturing Facilities: System & System Ca… | 2006 |
| * | K070240 | Carto XP EP Navigation System, Version 9Summary page 1…vigation System (K072202) CARTO RMT V8 EP Navigation System (K060047) CARTO V9 XP EP Navigation System (K070240) Manufacturing Facilities: System & System Cables Biosense Webster (Israel) Ltd.… | 2007 |
What descends from it? (45)
See all 452 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
| Feb 15, 2011 | Not classified | Z-1839-2011 | Other | The recall was initiated because Biosense Webster has confirmed that there is an inaccessibility of electronic version of the instruction for use (e-IFU) for the "10 ft. Interface Cable, 10 Pin-Shielded Tip Pins to 12 Pin-Blue", catalog… |
| Oct 5, 2010 | Not classified | Z-0884-2011 | Device Design | When connecting this cable to the mapping system, loss of Body Surface ECG signals may occur. This may result in inaccurate locations appearing for catheters displayed 3D on the CARTO monitor. |
| Nov 17, 2009 | Class II | Z-2369-2012 | Labeling mix-ups | The recall was initiated because Biosense Webster has become aware of information regarding a potential hazard that may occur during the operation of a Bloom EP Stimulator device in conjunction with RF generators and other… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K093455 (Biosense Webster, Inc., 2009) has gone furthest, with 34 descendants of its own.
- 1 other device also cites its predicate K072202.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 V1.0 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 V1.0 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 V1.0 System is also intended to support EP procedures, maintaining CARTO® System capabilities, in the presence of a high metallic environment and magnetic field strengths upto 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V1.0 System includes CARTOMERGE® PLUS functionality to import, register and merge CT or MRI structural images with CARTO® map's 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 CARTOSOUND 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, electrophysiology catheters without magnetic location sensors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090017: Carto 3 EP Navigation System, V1.0 and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090017
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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