510(k) · Cleared
Recalled · Class II · 2016Carto 3 EP Navigation System, Version 4.2
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 Jul 1, 2014 as substantially equivalent to K120550 (Biosense Webster, Inc., 2012) after a 190-day review. Its family tree reaches back 11 generations to 2000. 27 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 1, 2014
- Review
- 190 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 11 generations to K001437 (2000). 22 ancestors in all, the oldest K982415 (1998). 27 later devices descend from it, 6 citing it directly.
- Root · 11 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 7 generations between
- 3 generations backK103746 Carto 3 EP Navigation System, Version 2.0 (W/Standard Location…Biosense Webster, Inc. · 2011 · Recalled
- 2 generations backK112007 Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011 · Recalled
- 1 generation backK120550 Carto (R) EP Navigation System, Version 3.0 (with Standard Location…Biosense Webster, Inc. · 2012 · Recalled
- This deviceK133916 Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc. · 2014
- Descendant · cites it directly · 20 of its ownK170600 CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc. · 2017
- Descendant · 2 generations on · 19 of its ownK180238 CARTO 3 EP Navigation System, Version 6.0 and Accessories with…Biosense Webster, Inc. · 2018
- Descendant · 3 generations on · 16 of its ownK191660 CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 15 of its ownK200484 CARTO® 3 EP Navigation System with Signal Processing UnitBiosense Webster, Inc. · 2020
- Descendant · 4 generations on · 14 of its ownK213264 CARTO 3 EP Navigation System Version 7.2Biosense Webster, Inc. · 2021
Show all 11 generations
- Root · 11 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 10 generations backK012926 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2001
- 9 generations backK030129 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2003
- 8 generations backK042493 Ensite System, Model EE3000Endocardial Solutions, Inc. · 2004
- 7 generations backK060954 Modification to Ensite System, Model EE3000St. Jude Medical, Inc.-Endocardial Solutions · 2006
- 6 generations backK072202 Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External…Biosense Webster, Inc. · 2007
- 5 generations backK090017 Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- 4 generations backK093455 Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- 3 generations backK103746 Carto 3 EP Navigation System, Version 2.0 (W/Standard Location…Biosense Webster, Inc. · 2011 · Recalled
- 2 generations backK112007 Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011 · Recalled
- 1 generation backK120550 Carto (R) EP Navigation System, Version 3.0 (with Standard Location…Biosense Webster, Inc. · 2012 · Recalled
- This deviceK133916 Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc. · 2014
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K170600CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc. · 2017 · cites it directly20descendants
- K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINTBiosense Webster, Inc. · 2018 · 2 generations on19descendants
- K191660CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc. · 2019 · 3 generations on16descendants
- K200484CARTO® 3 EP Navigation System with Signal Processing UnitBiosense Webster, Inc. · 2020 · 4 generations on15descendants
- K213264CARTO 3 EP Navigation System Version 7.2Biosense Webster, Inc. · 2021 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001437 | Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2000 | — |
| −10 | K012926 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2001 | — |
| −9 | K030129 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2003 | — |
| −8 | K042493 | Ensite System, Model EE3000 | Endocardial Solutions, Inc. | 2004 | — |
| −7 | K060954 | Modification to Ensite System, Model EE3000 | St. Jude Medical, Inc.-Endocardial Solutions | 2006 | — |
| −6 | K072202 | Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference… | Biosense Webster, Inc. | 2007 | — |
| −5 | K090017 | Carto 3 EP Navigation System, V1.0 and Accessories | Biosense Webster, Inc. | 2009 | 4 |
| −4 | K093455 | Carto 3 Version 1.05 EP Navigation System and Accessories | Biosense Webster, Inc. | 2009 | 1 |
| −3 | K103746 | Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3… | Biosense Webster, Inc. | 2011 | 1 |
| −2 | K112007 | Carto 3 EP Navigation System, Version 2.2 | Biosense Webster, Inc. | 2011 | 2 |
| −1 | K120550 | Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad) | Biosense Webster, Inc. | 2012 | 2 |
| 0 (this device) | K133916 | Carto 3 EP Navigation System, Version 4.2 | Biosense Webster, Inc. | 2014 | — |
| +1 | K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | Biosense Webster, Inc. | 2017 | — |
| +2 | K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | Biosense Webster, Inc. | 2018 | — |
| +3 | K191660 | CARTO 3 EP Navigation System, Version 7.1 and Accessories | Biosense Webster, Inc. | 2019 | 1 |
| +4 | K200484 | CARTO® 3 EP Navigation System with Signal Processing Unit | Biosense Webster, Inc. | 2020 | — |
| +4 | K213264 | CARTO 3 EP Navigation System Version 7.2 | Biosense Webster, Inc. | 2021 | — |
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 |
|---|---|---|
| 2017 | 1 | 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 26.6 · 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 |
|---|---|---|---|
| * | K120550 | Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad)Summary page 1…iac mapping systém. , Programmab!e diagnostic computer. Class II;21 CFR:870.1425; Produict Code DQK i CARTO ‘3.EP Navigation Systern, Version 3.0, cleared via: 5]0(k) K120550 May 7. 2012. eferenced Devic ":’sl ‘Siemens. MAGNETOM Skyra with Syngo MR DI, 1y S10(K) K111242! cleared November 23,2011, ‘Ré… | 2012 |
| † | K111242 | Magnetom Aera and Magnetom Skyra | 2011 |
| † | K130727 | Ensite Velocity System | 2013 |
What descends from it? (27)
See all 276 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | 2017 | 20 |
| K173837 | RHYTHMIA HDx Mapping System (with software Version 2.0) | 2018 | 2 |
| K180940 | KODEX EPD System | 2018 | 1 |
| K233160 | NeuTrace EP Mapping System v.2.1 | 2023 | 0 |
| K173978 | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module | 2018 | 0 |
| K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module | 2018 | 0 |
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… |
| Sep 10, 2015 | Class II | Z-0002-2016 | Device Design | Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 22 ancestors have a recall of any class.
- Of its descendants, K170600 (Biosense Webster, Inc., 2017) has gone furthest, with 20 descendants of its own.
- 2 other devices also cite its predicate K120550.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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/K133916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133916: Carto 3 EP Navigation System, Version 4.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133916
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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