510(k) · Cleared
Recalled · Class II · 2020CARTO 3 EP Navigation System, Version 7.1 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 Jul 20, 2019 as substantially equivalent to K180238 (Biosense Webster, Inc., 2018) after a 29-day review. Its family tree reaches back 14 generations to 2000. 16 later devices descend from it. It has been recalled once.
- Decided
- Jul 20, 2019
- Review
- 29 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 14 generations to K001437 (2000). 25 ancestors in all, the oldest K982415 (1998). 16 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 10 generations between
- 3 generations backK133916 Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc. · 2014 · Recalled
- 2 generations backK170600 CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc. · 2017
- 1 generation backK180238 CARTO 3 EP Navigation System, Version 6.0 and Accessories with…Biosense Webster, Inc. · 2018
- This deviceK191660 CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc. · 2019
- Descendant · cites it directly · 15 of its ownK200484 CARTO® 3 EP Navigation System with Signal Processing UnitBiosense Webster, Inc. · 2020
- Descendant · cites it directly · 14 of its ownK213264 CARTO 3 EP Navigation System Version 7.2Biosense Webster, Inc. · 2021
- Descendant · 2 generations on · 6 of its ownK223733 CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4Biosense Webster, Inc. · 2023
- Descendant · 2 generations on · 5 of its ownK233943 Affera Mapping System (AFR-00003); Location Reference Patch Kit…Medtronic, Inc. · 2024
- Descendant · 3 generations on · 5 of its ownK231207 CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Biosense Webster, Inc. · 2023
Show all 14 generations
- Root · 14 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 13 generations backK012926 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2001
- 12 generations backK030129 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2003
- 11 generations backK042493 Ensite System, Model EE3000Endocardial Solutions, Inc. · 2004
- 10 generations backK060954 Modification to Ensite System, Model EE3000St. Jude Medical, Inc.-Endocardial Solutions · 2006
- 9 generations backK072202 Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External…Biosense Webster, Inc. · 2007
- 8 generations backK090017 Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- 7 generations backK093455 Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- 6 generations backK103746 Carto 3 EP Navigation System, Version 2.0 (W/Standard Location…Biosense Webster, Inc. · 2011 · Recalled
- 5 generations backK112007 Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011 · Recalled
- 4 generations backK120550 Carto (R) EP Navigation System, Version 3.0 (with Standard Location…Biosense Webster, Inc. · 2012 · Recalled
- 3 generations backK133916 Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc. · 2014 · Recalled
- 2 generations backK170600 CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc. · 2017
- 1 generation backK180238 CARTO 3 EP Navigation System, Version 6.0 and Accessories with…Biosense Webster, Inc. · 2018
- This deviceK191660 CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc. · 2019
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K200484CARTO® 3 EP Navigation System with Signal Processing UnitBiosense Webster, Inc. · 2020 · cites it directly15descendants
- K213264CARTO 3 EP Navigation System Version 7.2Biosense Webster, Inc. · 2021 · cites it directly14descendants
- K223733CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4Biosense Webster, Inc. · 2023 · 2 generations on6descendants
- K233943Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart…Medtronic, Inc. · 2024 · 2 generations on5descendants
- K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Biosense Webster, Inc. · 2023 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K001437 | Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2000 | — |
| −13 | K012926 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2001 | — |
| −12 | K030129 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2003 | — |
| −11 | K042493 | Ensite System, Model EE3000 | Endocardial Solutions, Inc. | 2004 | — |
| −10 | K060954 | Modification to Ensite System, Model EE3000 | St. Jude Medical, Inc.-Endocardial Solutions | 2006 | — |
| −9 | K072202 | Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference… | Biosense Webster, Inc. | 2007 | — |
| −8 | K090017 | Carto 3 EP Navigation System, V1.0 and Accessories | Biosense Webster, Inc. | 2009 | 4 |
| −7 | K093455 | Carto 3 Version 1.05 EP Navigation System and Accessories | Biosense Webster, Inc. | 2009 | 1 |
| −6 | K103746 | Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3… | Biosense Webster, Inc. | 2011 | 1 |
| −5 | 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 |
| −3 | K133916 | Carto 3 EP Navigation System, Version 4.2 | Biosense Webster, Inc. | 2014 | 2 |
| −2 | K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | Biosense Webster, Inc. | 2017 | — |
| −1 | K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | Biosense Webster, Inc. | 2018 | — |
| 0 (this device) | K191660 | CARTO 3 EP Navigation System, Version 7.1 and Accessories | Biosense Webster, Inc. | 2019 | — |
| +1 | K200484 | CARTO® 3 EP Navigation System with Signal Processing Unit | Biosense Webster, Inc. | 2020 | — |
| +1 | K213264 | CARTO 3 EP Navigation System Version 7.2 | Biosense Webster, Inc. | 2021 | — |
| +2 | K223733 | CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 | Biosense Webster, Inc. | 2023 | — |
| +2 | K233943 | Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007)… | Medtronic, Inc. | 2024 | — |
| +3 | K231207 | CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | Biosense Webster, Inc. | 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 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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 26.6 · 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? (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 |
|---|---|---|---|
| * | K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINTSummary page 4…DQK Predicate Device: CARTO® 3 EP Navigation System Version 6.0 and Accessories with VISITAG SURPOINT 510(k)#: K180238 Manufacturing Biosense Webster (Israel), Ltd. Facilities: a Johnson & Johnson Company… | 2018 |
| † | K173978 | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module | 2018 |
| † | K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module | 2018 |
What descends from it? (16)
See all 162 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 |
|---|---|---|---|---|
| Jun 22, 2020 | Class II | Z-2880-2020 | Software design | Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation sites. This may lead to prolongation of the procedure and, in extremely rare circumstances, cardiac perforation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 25 ancestors have a recall of any class.
- Of its descendants, K200484 (Biosense Webster, Inc., 2020) has gone furthest, with 15 descendants of its own.
- 1 other device also cites its predicate K180238.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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® 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.
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/K191660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191660: CARTO 3 EP Navigation System, Version 7.1 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/K191660
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