510(k) · Cleared
ClearedModification to Carto EP Navigation System
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 Dec 3, 1999 as substantially equivalent to K992968 (Biosense Webster, Inc., 1999) after a 29-day review. Its family tree reaches back 2 generations to 1995. 34 later devices descend from it.
- Decided
- Dec 3, 1999
- Review
- 29 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954395 (1995). 34 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK954395 Carto SystemBiosense, Ltd. · 1995
- 1 generation backK992968 Carto EP Navigation SystemBiosense Webster, Inc. · 1999
- This deviceK993729 Modification to Carto EP Navigation SystemBiosense Webster, Inc. · 1999
- Descendant · cites it directly · 33 of its ownK063277 MapmateEp Medsystems, Inc. · 2006
- Descendant · 2 generations on · 32 of its ownK092810 EP-Workmate System, Version 4.2St Jude Medical · 2009
- Descendant · 3 generations on · 31 of its ownK132073 EP-Workmate, EP-Nursemate, EP-Nursemate with Physio ModuleSt Jude Medical · 2013
- Descendant · 4 generations on · 30 of its ownK151911 WorkMate Claris System, WorkMate Claris System Display PlusSt Jude Medical · 2015
- Descendant · 5 generations on · 28 of its ownK160218 AutoMark ModuleSt Jude Medical · 2016
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K063277MapmateEp Medsystems, Inc. · 2006 · cites it directly33descendants
- K092810EP-Workmate System, Version 4.2St Jude Medical · 2009 · 2 generations on32descendants
- K132073EP-Workmate, EP-Nursemate, EP-Nursemate with Physio ModuleSt Jude Medical · 2013 · 3 generations on31descendants
- K151911WorkMate Claris System, WorkMate Claris System Display PlusSt Jude Medical · 2015 · 4 generations on30descendants
- K160218AutoMark ModuleSt Jude Medical · 2016 · 5 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954395 | Carto System | Biosense, Ltd. | 1995 | — |
| −1 | K992968 | Carto EP Navigation System | Biosense Webster, Inc. | 1999 | — |
| 0 (this device) | K993729 | Modification to Carto EP Navigation System | Biosense Webster, Inc. | 1999 | — |
| +1 | K063277 | Mapmate | Ep Medsystems, Inc. | 2006 | — |
| +2 | K092810 | EP-Workmate System, Version 4.2 | St Jude Medical | 2009 | — |
| +3 | K132073 | EP-Workmate, EP-Nursemate, EP-Nursemate with Physio Module | St Jude Medical | 2013 | — |
| +4 | K151911 | WorkMate Claris System, WorkMate Claris System Display Plus | St Jude Medical | 2015 | — |
| +5 | K160218 | AutoMark Module | St Jude Medical | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 8 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K992968 | Carto EP Navigation SystemSummary page 1…ation name: Programmable diagnostic computer (per 21 CFR 870.1425) Common device name: Cardiac mapping system Cleared unmodified device CARTO mapping system 510(k) No. K992968 The CARTO EP Navigation System is designed to acquire, analyze, and display electro- anatomical maps of the human heart. The map… | 1999 |
What descends from it? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063277 | Mapmate | 2006 | 33 |
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 4 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K063277 (Ep Medsystems, Inc., 2006) has gone furthest, with 33 descendants of its own.
- 2 other devices also cite its predicate K992968.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 EP Navigation System is catheter-based cardiac mapping.
The CARTO EP Navigation System allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps and cardiac impedance maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.
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/K993729 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993729: Modification to Carto EP Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993729
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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