510(k) Report

510(k) · Cleared

Cleared

Mapmate

K063277510(k) SpecialCleared Nov 30, 200630-day reviewClass II21 CFR 870.1425

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ep Medsystems, Inc. · DQK Computer, Diagnostic, Programmable

Cleared on Nov 30, 2006 as substantially equivalent to K994011 (Ep Medsystems, Inc., 2000) and 9 other predicates after a 30-day review. Its family tree reaches back 4 generations to 2000. 33 later devices descend from it.

Decided
Nov 30, 2006
Review
30 days
Class
Class II
Product code
DQK
Recalls
None
Predicates
10

Its longest line of descent runs back 4 generations to K000248 (2000). 10 ancestors in all, the oldest K954395 (1995). 33 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2000: 2 other ancestors1999: 2 other ancestors1995: 1 other ancestor2009: 1 descendant cleared2013: 1 descendant cleared2015: 1 descendant cleared2016: 1 descendant cleared2021: 3 descendants cleared2018: 3 descendants cleared2020: 3 descendants cleared2024: 3 descendants cleared2025: 8 descendants cleared2026: 6 descendants cleared2022: 2 descendants cleared2023: 1 descendant clearedK000248 · Carto EP Navigation System · Biosense Webster, Inc. · 2000K013083 · Carto XP EP Navigation System · Biosense Webster, Inc. · 2001K020863 · Carto XP and Qwikmap EP Navigation System · Biosense Webster, Inc. · 2003K042999 · Carto XP EP Navigation System, Software Verison 8 · Biosense Webster, Inc. · 20051995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 1 descendant8 generations forward: 2 descendants9 generations forward: 2 descendants10 generations forward: 5 descendants11 generations forward: 4 descendants12 generations forward: 1 descendant13 generations forward: 1 descendant14 generations forward: 1 descendant15 generations forward: 1 descendant16 generations forward: 4 descendants17 generations forward: 2 descendants18 generations forward: 2 descendants K042999 · Carto XP EP Navigation System, Software Verison 8 · Biosense Webster, Inc. · 2005K020863 · Carto XP and Qwikmap EP Navigation System · Biosense Webster, Inc. · 2003K013083 · Carto XP EP Navigation System · Biosense Webster, Inc. · 2001K000248 · Carto EP Navigation System · Biosense Webster, Inc. · 20000+5+10+15
  1. Root · 4 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
  2. 3 generations backK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
  3. 2 generations backK020863 Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003
  4. 1 generation backK042999 Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005
  5. This deviceK063277 MapmateEp Medsystems, Inc. · 2006
  6. Descendant · cites it directly · 32 of its ownK092810 EP-Workmate System, Version 4.2St Jude Medical · 2009
  7. Descendant · 2 generations on · 31 of its ownK132073 EP-Workmate, EP-Nursemate, EP-Nursemate with Physio ModuleSt Jude Medical · 2013
  8. Descendant · 3 generations on · 30 of its ownK151911 WorkMate Claris System, WorkMate Claris System Display PlusSt Jude Medical · 2015
  9. Descendant · 4 generations on · 28 of its ownK160218 AutoMark ModuleSt Jude Medical · 2016
  10. Descendant · 5 generations on · 27 of its ownK172396 EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2009: 12013: 12015: 12016: 12018: 32020: 32021: 32022: 22023: 12024: 32025: 82026: 6
2009high 8 (2025) · low 0 (2010)2026

Most influential descendants

Showing 5 of 33 · See all
  • K092810EP-Workmate System, Version 4.2St Jude Medical · 2009 · cites it directly32descendants
  • K132073EP-Workmate, EP-Nursemate, EP-Nursemate with Physio ModuleSt Jude Medical · 2013 · 2 generations on31descendants
  • K151911WorkMate Claris System, WorkMate Claris System Display PlusSt Jude Medical · 2015 · 3 generations on30descendants
  • K160218AutoMark ModuleSt Jude Medical · 2016 · 4 generations on28descendants
  • K172396EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018 · 5 generations on27descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K000248Carto EP Navigation SystemBiosense Webster, Inc.2000—
−3K013083Carto XP EP Navigation SystemBiosense Webster, Inc.2001—
−2K020863Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc.2003—
−1K042999Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc.2005—
0 (this device)K063277MapmateEp Medsystems, Inc.2006—
+1K092810EP-Workmate System, Version 4.2St Jude Medical2009—
+2K132073EP-Workmate, EP-Nursemate, EP-Nursemate with Physio ModuleSt Jude Medical2013—
+3K151911WorkMate Claris System, WorkMate Claris System Display PlusSt Jude Medical2015—
+4K160218AutoMark ModuleSt Jude Medical2016—
+5K172396EnSite Velocity Cardiac Mapping System v5.2St Jude Medical2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199920
200020
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201310
201510
201610
201830
202030
202130
202220
202310
202430
202580
202660
FIG. 1 — Lineage of K063277, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (10)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K994011EP Medsystems, EP-Workmate
Summary page 1
…computers. 4.0 *Predicate Devices I Technolo EPWork ate' K994011 03/23/00 Carto RMT EP Navigation System K042681 09/29…
Ep Medsystems, Inc.20001
*K042681Carto RMT EP Navigation System
Summary page 1
…K994011 03/23/00 Carto RMT EP Navigation System K042681 09/29/05 Carto XP EP Navigation System Software Version 8 K042999 03/21…
Biosense Webster, Inc.2005—
*K042999Carto XP EP Navigation System, Software Verison 8
Summary page 1
…System K042681 09/29/05 Carto XP EP Navigation System Software Version 8 K042999 03/21/05 Carto EP and Qwickmap EP Navigation System K020863 01/09…
Biosense Webster, Inc.2005—
*K020863Carto XP and Qwikmap EP Navigation System
Summary page 1
…System Software Version 8 K042999 03/21/05 Carto EP and Qwickmap EP Navigation System K020863 01/09/03 Carto XP EP Navigation System K013083 11/21…
Biosense Webster, Inc.2003—
*K013083Carto XP EP Navigation System
Summary page 1
…P Navigation System K020863 01/09/03 Carto XP EP Navigation System K013083 11/21/01 Carto EP Navigation System K000248 05/05…
Biosense Webster, Inc.2001—
*K000248Carto EP Navigation System
Summary page 1
…System K013083 11/21/01 Carto EP Navigation System K000248 05/05/00 Modification to Carto EP Navigation System K000190 05/05…
Biosense Webster, Inc.2000—
*K000190Modification to Carto EP Navigation System
Summary page 1
…tem K000248 05/05/00 Modification to Carto EP Navigation System K000190 05/05/00 Modification to Carto EP Navigation System K993729 12/03…
Biosense Webster, Inc.2000—
*K993729Modification to Carto EP Navigation System
Summary page 1
…P Navigation System K000190 05/05/00 Modification to Carto EP Navigation System K993729 12/03/99 Carto EP Navigation System K992968 09/29…
Biosense Webster, Inc.1999—
*K992968Carto EP Navigation System
Summary page 1
…P Navigation System K993729 12/03/99 Carto EP Navigation System K992968 09/29/99 This document is the property of EPMedSystems. Its' entire content is considered proprietary and confidential b…
Biosense Webster, Inc.1999—
*K954395Carto System
Summary page 2
…Systems 510(k) Summary Carto System K954395 1/19 ® * This application describes a modifi…
Biosense, Ltd.1995—

Also cleared against K994011: 2 other devices →

What descends from it? (33)

See all 33

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092810EP-Workmate System, Version 4.2St Jude Medical200932

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 6 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
  • 1 of the 10 ancestors has a recall of any class.
  • Of its descendants, K092810 (St Jude Medical, 2009) has gone furthest, with 32 descendants of its own.
  • 2 other devices also cite its predicate K994011.

How does its category compare?

All DQK devices

DQK 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

2007: 132008: 42009: 122010: 92011: 122012: 72013: 132014: 92015: 72016: 152017: 72018: 142019: 152020: 162021: 162022: 192023: 212024: 132025: 222026 (partial year): 23
2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007: 83 days median2008: 70 days median2009: 93 days median2010: 64 days median2011: 69 days median2012: 74 days median2013: 68 days median2014: 90 days median2015: 125 days median2016: 190 days median2017: 146 days median2018: 150 days median2019: 113 days median2020: 123 days median2021: 132 days median2022: 136 days median2023: 133 days median2024: 100 days median2025: 95 days median2026 (partial year): 151 days median
2007high 190 (2016) · low 64 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQK

1in 2025

2007: 42008: 12009: 22010: 32011: 22012: 32013: 12014: 42015: 22017: 22018: 62019: 12020: 12021: 12022: 22023: 22024: 242025: 12026 (partial year): 2
2007high 24 (2024) · low 0 (2016)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQK

433in 2025

2007: 182008: 342009: 402010: 492011: 552012: 1292013: 1802014: 1152015: 1312016: 3402017: 2522018: 2612019: 2182020: 2152021: 3512022: 3192023: 3402024: 5572025: 433
2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071383418
2008470134
20091293240
2010964349
20111269255
20127743129
201313681180
20149904115
201571252131
2016151900340
201771462252
2018141506261
2019151131218
2020161231215
2021161321351
2022191362319
2023211332340
20241310024557
202522951433
2026231512—

What is it indicated for?

MapMate™ is indicated for use during clinical electrophysiology procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K994011

2 other devices cite the same predicate.

  • K070706EP-WorkmateEp Medsystems · 20071 recall
  • K063113EP-WorkmateEp Medsystems · 2006

More from Ep Medsystems, Inc.

3 FDA decisions under this applicant name. See the company

  • K033963EP Deflectable CathetersEp Medsystems, Inc. · 2004
  • K994011EP Medsystems, EP-WorkmateEp Medsystems, Inc. · 20001 recall

Recent decisions in DQK

The DQK category page

  • K263380STAR Apollo™ Mapping SystemRhythm AI, Ltd. · 2026
  • K263016Intra-Operative Positioning System (IOPS) and IOPS Visionary SystemCenterline Biomedical · 2026
  • K261729EnSite™ X EP SystemAbbott Medical · 2026
  • K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific · 2026
  • K262005Affera Integrated Mapping SystemMedtronic, Inc. · 2026

https://510kreport.com/device/K063277 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063277: Mapmate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063277

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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