510(k) · Cleared
Recalled · Class II · 2021WorkMate Claris System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott · DQK Computer, Diagnostic, Programmable
Cleared on Mar 11, 2021 as substantially equivalent to K151911 (St Jude Medical, 2015) after a 29-day review. Its family tree reaches back 8 generations to 2000. It has been recalled 3 times.
- Decided
- Mar 11, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 8 generations to K000248 (2000). 15 ancestors in all, the oldest K954395 (1995). No later device cites it as a predicate yet.
- Root · 8 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 7 generations backK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
- 6 generations backK020863 Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003
- 5 generations backK042999 Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005
- 4 generations backK063277 MapmateEp Medsystems, Inc. · 2006
- 3 generations backK092810 EP-Workmate System, Version 4.2St Jude Medical · 2009
- 2 generations backK132073 EP-Workmate, EP-Nursemate, EP-Nursemate with Physio ModuleSt Jude Medical · 2013
- 1 generation backK151911 WorkMate Claris System, WorkMate Claris System Display PlusSt Jude Medical · 2015
- This deviceK210392 WorkMate Claris SystemAbbott · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K000248 | Carto EP Navigation System | Biosense Webster, Inc. | 2000 | — |
| −7 | K013083 | Carto XP EP Navigation System | Biosense Webster, Inc. | 2001 | — |
| −6 | K020863 | Carto XP and Qwikmap EP Navigation System | Biosense Webster, Inc. | 2003 | — |
| −5 | K042999 | Carto XP EP Navigation System, Software Verison 8 | Biosense Webster, Inc. | 2005 | — |
| −4 | K063277 | Mapmate | Ep Medsystems, Inc. | 2006 | — |
| −3 | K092810 | EP-Workmate System, Version 4.2 | St Jude Medical | 2009 | — |
| −2 | K132073 | EP-Workmate, EP-Nursemate, EP-Nursemate with Physio Module | St Jude Medical | 2013 | — |
| −1 | K151911 | WorkMate Claris System, WorkMate Claris System Display Plus | St Jude Medical | 2015 | — |
| 0 (this device) | K210392 | WorkMate Claris System | Abbott | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 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 |
|---|---|---|---|
| * | K151911 | WorkMate Claris System, WorkMate Claris System Display PlusSummary page 4…II Classification Name 870.1425, computer, diagnostic, programmable Product Code DQK Predicate Device Workmate Claris™ System v1.1 (K151911) Reference Applications N/A Device Description The WorkMate Claris™ System is a fully computerized system for capturing a… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 5, 2021 | Class II | Z-1854-2021 | Software Manufacturing/Software Deployment | Due to a software error, the user may lose functionality of the system or the screen may turn black during operation. |
| May 5, 2021 | Class II | Z-1853-2021 | Software Manufacturing/Software Deployment | Due to a software error, the user may lose functionality of the system or the screen may turn black during operation. |
| May 5, 2021 | Class II | Z-1855-2021 | Software Manufacturing/Software Deployment | Due to a software error, the user may lose functionality of the system or the screen may turn black during operation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 1 other device also cites its predicate K151911.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 WorkMate ClarisTm System is indicated for the use during clinical electrophysiology procedures.
The WorkMate Claris System is a fully computerized system for capturing and measuring physiological data in the clinical electrophysiology (EP) laboratory. It provides digital signal acquisition and display of those electrical signals on high resolution monitors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210392: WorkMate Claris System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210392
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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