510(k) · Cleared
ClearedCarto 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 Sep 29, 1999 as substantially equivalent to K954395 (Biosense, Ltd., 1995) after a 26-day review. Its family tree reaches back 1 generation to 1995. 36 later devices descend from it.
- Decided
- Sep 29, 1999
- Review
- 26 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954395 (1995). 36 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK954395 Carto SystemBiosense, Ltd. · 1995
- This deviceK992968 Carto EP Navigation SystemBiosense Webster, Inc. · 1999
- Descendant · cites it directly · 34 of its ownK993729 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
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K993729Modification to Carto EP Navigation SystemBiosense Webster, Inc. · 1999 · cites it directly34descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954395 | Carto System | Biosense, Ltd. | 1995 | — |
| 0 (this device) | K992968 | Carto EP Navigation System | Biosense Webster, Inc. | 1999 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K954395 | Carto 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. K954395 The CARTO mapping system is designed to acquire, analyze, and display electro- anatomical maps of the human heart. The maps are… | 1995 |
What descends from it? (36)
See all 363 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?
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 mapping system is catheter-based cardiac mapping.
The CARTO mapping 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/K992968 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992968: 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/K992968
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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