510(k) · Cleared
ClearedLabsystem Iii EP Laboratory W/Windows Platform & Windows EP Software Version 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Jun 3, 2003 as substantially equivalent to K883152 (Coherent Systems, Inc., 1988) and 2 other predicates after a 64-day review. Its family tree reaches back 1 generation to 1988. 14 later devices descend from it.
- Decided
- Jun 3, 2003
- Review
- 64 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K874441 (1988). 3 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK874441 Bard Biopotential AmplifierC.R. Bard, Inc. · 1988
- This deviceK031000 Labsystem Iii EP Laboratory W/Windows Platform & Windows EP Software…C.R. Bard, Inc. · 2003
- Descendant · cites it directly · 13 of its ownK101331 Labsystem Pro EP Recording System V3.1 SoftwareC.R. Bard Inc., Bard Electrophysiology Division · 2010
- Descendant · cites it directly · 12 of its ownK113811 V2.6 Software for the Labsystem Pro EP Recording SystemC.R. Bard Inc., Bard Electrophysiology Division · 2012
- Descendant · 2 generations on · 8 of its ownK140497 Ecvue Mapping SystemCardioinsight Technologies, Inc. · 2014
- Descendant · 3 generations on · 7 of its ownK150990 ECVUE Mapping SystemCardioinsight Technologies, Inc. · 2015
- Descendant · 4 generations on · 6 of its ownK162440 CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K101331Labsystem Pro EP Recording System V3.1 SoftwareC.R. Bard Inc., Bard Electrophysiology Division · 2010 · cites it directly13descendants
- K113811V2.6 Software for the Labsystem Pro EP Recording SystemC.R. Bard Inc., Bard Electrophysiology Division · 2012 · cites it directly12descendants
- K140497Ecvue Mapping SystemCardioinsight Technologies, Inc. · 2014 · 2 generations on8descendants
- K150990ECVUE Mapping SystemCardioinsight Technologies, Inc. · 2015 · 3 generations on7descendants
- K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. · 2016 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874441 | Bard Biopotential Amplifier | C.R. Bard, Inc. | 1988 | — |
| 0 (this device) | K031000 | Labsystem Iii EP Laboratory W/Windows Platform & Windows EP Software Version 1.0 | C.R. Bard, Inc. | 2003 | — |
| +1 | 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 | — |
| +2 | K140497 | Ecvue Mapping System | Cardioinsight Technologies, Inc. | 2014 | — |
| +3 | K150990 | ECVUE Mapping System | Cardioinsight Technologies, Inc. | 2015 | — |
| +4 | K162440 | CardioInsight Cardiac Mapping System | Cardioinsight Technologies, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 26.7 · 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K883152 | EP-StatSummary page 1…6.3 Predicate Device Name(s): The Coherent Systems, Inc. - Coherent EP-STAT System* (K883152/0ctober 13, 1988) C.R. Bard, Inc. - Bard BioPotential Amplifier… | 1988 |
| * | K874441 | Bard Biopotential AmplifierSummary page 1…(K883152/0ctober 13, 1988) C.R. Bard, Inc. - Bard BioPotential Amplifier (K874441/February 19, 1988) C.R. Bard, Inc. - Bard BioPotential Amplifier II -… | 1988 |
| * | K901358 | Bard Biopotential Amplifier IISummary page 1…. - Bard BioPotential Amplifier II - STAMP (K901358/November 27, 1991) Bard Electrophysiology -High Level Input Isolation Module Divis… | 1990 |
| Kept off the family tree | K953267 | High Level Input Isolation Module Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…(K901358/November 27, 1991) Bard Electrophysiology -High Level Input Isolation Module Division of C.R. Bard, Inc. (K953267/February 27, 1996) *Acquired by Bard in March 1989 and renamed the Bard Labsystem EP Laborator… | |
| † | K913875 | Bard (R) Biopotential Amplifier II | 1991 |
What descends from it? (14)
See all 143 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?
- None of the 3 ancestors has a recall.
- Of its descendants, K101331 (C.R. Bard Inc., Bard Electrophysiology Division, 2010) has gone furthest, with 13 descendants of its own.
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 Bard Labsystem Ill* 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.
The Bard STAMP Amplifier is intended to amplify and condition
electrocardiographic signals of biologic origin and pressure transducer
input, transmitting this information to a host computer (the Bard
LabSystem [Ill]* EP Laboratory) that can record and display the
information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031000 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031000: Labsystem Iii EP Laboratory W/Windows Platform & Windows EP Software Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031000
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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