510(k) · Cleared
ClearedCARTO™ 3 EP Navigation System V8.1
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 Aug 22, 2025 as substantially equivalent to K231207 (Biosense Webster, Inc., 2023) after a 29-day review. Its family tree reaches back 19 generations to 2000. 2 later devices descend from it.
- Decided
- Aug 22, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K001437 (2000). 30 ancestors in all, the oldest K982415 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 19 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 15 generations between
- 3 generations backK213264 CARTO 3 EP Navigation System Version 7.2Biosense Webster, Inc. · 2021
- 2 generations backK223733 CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4Biosense Webster, Inc. · 2023
- 1 generation backK231207 CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Biosense Webster, Inc. · 2023
- This deviceK252302 CARTO™ 3 EP Navigation System V8.1Biosense Webster, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK252972 CARTO™ 3 EP Navigation System V8.4Biosense Webster, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK254085 CARTO™ 3 EP Navigation System V9.0 with PIU PlusBiosense Webster, Inc. · 2026
Show all 19 generations
- Root · 19 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
- 18 generations backK012926 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2001
- 17 generations backK030129 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2003
- 16 generations backK042493 Ensite System, Model EE3000Endocardial Solutions, Inc. · 2004
- 15 generations backK060954 Modification to Ensite System, Model EE3000St. Jude Medical, Inc.-Endocardial Solutions · 2006
- 14 generations backK072202 Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External…Biosense Webster, Inc. · 2007
- 13 generations backK090017 Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- 12 generations backK093455 Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- 11 generations backK103746 Carto 3 EP Navigation System, Version 2.0 (W/Standard Location…Biosense Webster, Inc. · 2011 · Recalled
- 10 generations backK112007 Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011 · Recalled
- 9 generations backK120550 Carto (R) EP Navigation System, Version 3.0 (with Standard Location…Biosense Webster, Inc. · 2012 · Recalled
- 8 generations backK133916 Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc. · 2014 · Recalled
- 7 generations backK170600 CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc. · 2017
- 6 generations backK180238 CARTO 3 EP Navigation System, Version 6.0 and Accessories with…Biosense Webster, Inc. · 2018
- 5 generations backK191660 CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc. · 2019 · Recalled
- 4 generations backK200484 CARTO® 3 EP Navigation System with Signal Processing UnitBiosense Webster, Inc. · 2020
- 3 generations backK213264 CARTO 3 EP Navigation System Version 7.2Biosense Webster, Inc. · 2021
- 2 generations backK223733 CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4Biosense Webster, Inc. · 2023
- 1 generation backK231207 CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Biosense Webster, Inc. · 2023
- This deviceK252302 CARTO™ 3 EP Navigation System V8.1Biosense Webster, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K001437 | Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2000 | — |
| −18 | K012926 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2001 | — |
| −17 | K030129 | Modification to Ensite 3000 System, Model EE3000 | Endocardial Solutions, Inc. | 2003 | — |
| −16 | K042493 | Ensite System, Model EE3000 | Endocardial Solutions, Inc. | 2004 | — |
| −15 | K060954 | Modification to Ensite System, Model EE3000 | St. Jude Medical, Inc.-Endocardial Solutions | 2006 | — |
| −14 | K072202 | Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference… | Biosense Webster, Inc. | 2007 | — |
| −13 | K090017 | Carto 3 EP Navigation System, V1.0 and Accessories | Biosense Webster, Inc. | 2009 | 4 |
| −12 | K093455 | Carto 3 Version 1.05 EP Navigation System and Accessories | Biosense Webster, Inc. | 2009 | 1 |
| −11 | K103746 | Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3… | Biosense Webster, Inc. | 2011 | 1 |
| −10 | K112007 | Carto 3 EP Navigation System, Version 2.2 | Biosense Webster, Inc. | 2011 | 2 |
| −9 | K120550 | Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad) | Biosense Webster, Inc. | 2012 | 2 |
| −8 | K133916 | Carto 3 EP Navigation System, Version 4.2 | Biosense Webster, Inc. | 2014 | 2 |
| −7 | K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | Biosense Webster, Inc. | 2017 | — |
| −6 | 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 |
| −4 | K200484 | CARTO® 3 EP Navigation System with Signal Processing Unit | Biosense Webster, Inc. | 2020 | — |
| −3 | 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 | — |
| −1 | K231207 | CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | Biosense Webster, Inc. | 2023 | — |
| 0 (this device) | K252302 | CARTO™ 3 EP Navigation System V8.1 | Biosense Webster, Inc. | 2025 | — |
| +1 | K252972 | CARTO™ 3 EP Navigation System V8.4 | Biosense Webster, Inc. | 2026 | — |
| +1 | K254085 | CARTO™ 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster, Inc. | 2026 | — |
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 |
|---|---|---|
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K231207 | CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Summary page 5…Programmable diagnostic computer Classification: Class II, 21 CFR 870.1425 Product Code DQK Predicate CARTO® 3 EP Navigation System Version 8.0 510(k)#: K231207 Device: 1 of 5 Manufacturing Biose… | 2023 |
What descends from it? (2)
2 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 25 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 30 ancestors have a recall of any class.
- Of its descendants, K252972 (Biosense Webster, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K231207.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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/K252302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252302: CARTO™ 3 EP Navigation System V8.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252302
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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