510(k) · Cleared
ClearedV2.7 Software for the Labsystem Pro EP Recording System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DQK Computer, Diagnostic, Programmable
Cleared on Jun 6, 2014 as substantially equivalent to K031000 (C.R. Bard, Inc., 2003) and 1 other predicate after a 30-day review. Its family tree reaches back 6 generations to 2000. 2 later devices descend from it.
- Decided
- Jun 6, 2014
- Review
- 30 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K000248 (2000). 13 ancestors in all, the oldest K874441 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 5 generations backK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
- 4 generations backK020863 Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003
- 3 generations backK042999 Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005
- 2 generations backK101331 Labsystem Pro EP Recording System V3.1 SoftwareC.R. Bard Inc., Bard Electrophysiology Division · 2010
- 1 generation backK113811 V2.6 Software for the Labsystem Pro EP Recording SystemC.R. Bard Inc., Bard Electrophysiology Division · 2012
- This deviceK141185 V2.7 Software for the Labsystem Pro EP Recording SystemBoston Scientific Corp · 2014
- Descendant · cites it directly · 1 of its ownK230008 Ablamap® SystemAblacon, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK251344 OptiMap™ SystemBoston Scientific Corporation · 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 |
|---|---|---|---|---|---|
| −6 | K000248 | Carto EP Navigation System | Biosense Webster, Inc. | 2000 | — |
| −5 | K013083 | Carto XP EP Navigation System | Biosense Webster, Inc. | 2001 | — |
| −4 | K020863 | Carto XP and Qwikmap EP Navigation System | Biosense Webster, Inc. | 2003 | — |
| −3 | K042999 | Carto XP EP Navigation System, Software Verison 8 | Biosense Webster, Inc. | 2005 | — |
| −2 | K101331 | Labsystem Pro EP Recording System V3.1 Software | C.R. Bard Inc., Bard Electrophysiology Division | 2010 | — |
| −1 | K113811 | V2.6 Software for the Labsystem Pro EP Recording System | C.R. Bard Inc., Bard Electrophysiology Division | 2012 | — |
| 0 (this device) | K141185 | V2.7 Software for the Labsystem Pro EP Recording System | Boston Scientific Corp | 2014 | — |
| +1 | K230008 | Ablamap® System | Ablacon, Inc. | 2023 | — |
| +2 | K251344 | OptiMap™ System | Boston Scientific Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K031000 | Labsystem Iii EP Laboratory W/Windows Platform & Windows EP Software Version 1.0Summary page 1…Programmable Diagnostic Computer Product Code: DQK Predicate Device(s): Bard LabSystem PRO EP Recording System (K031000/June 3, 2003) Special 510(k) Submission 2 May 2014 V2.7 Software for the Lab… | 2003 |
| * | K113811 | V2.6 Software for the Labsystem Pro EP Recording SystemSummary page 2…Page 2 of 5 V2.6 Software for the Bard LabSystem PRO EP Recording System (K1 138111/April 3, 2012) Device Description: The V2.7 software for the LabSystem TM PRO EP Recording System is substantially s… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230008 | Ablamap® System | 2023 | 1 |
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 14 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K230008 (Ablacon, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K031000.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 LabSystem EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data. When integrated with the Biosense Webster CARTO 3 system, the Bard LabSystem PRO EP Recording System is designed to: a) send patient demographics to Biosense Webster CARTO 3, and b) acquire (from Biosense Webster CARTO 3), store…
Read the full statement (144 words)
The LabSystem EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data.
When integrated with the Biosense Webster CARTO 3 system, the Bard LabSystem PRO EP Recording System is designed to: a) send patient demographics to Biosense Webster CARTO 3, and b) acquire (from Biosense Webster CARTO 3), store and display: i) synchronized 3D mapping events, ii) stimulation pacing data, and iii) images of completed 3D electro-anatomical maps of the human heart. The 3D mapping events and images are created by the Biosense Webster CARTO 3 device and stored on the Bard LabSystem PRO EP Recording System for review and insertion into the final clinical report. Integration also supports bidirectional communication of stimulation pacing channel selection and information sharing between the two systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141185: V2.7 Software for the Labsystem Pro EP Recording System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141185
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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