510(k) · Cleared
Recalled · Class II · 2017EP-Tracer System, EP-Tracer System, EP-Tracer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardio Tek, BV · DQK Computer, Diagnostic, Programmable
Cleared on Mar 31, 2014 as substantially equivalent to K071348 (Mennen Medical, Ltd., 2007) after a 90-day review. Its family tree reaches back 4 generations to 1986. 5 later devices descend from it. It has been recalled once.
- Decided
- Mar 31, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K862740 (1986). 10 ancestors in all, the oldest K854196 (1986). 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK862740 Quinton Q.CathQuinton, Inc. · 1986
- 3 generations backK971570 Epxpress System (Timberwolf Revision) /000391Quinton Electrophysiology Corp. · 1997
- 2 generations backK993414 Prucka Engineering Inc. Cardiolab EP System,Version 4.2Prucka Engineering, Inc. · 2000
- 1 generation backK071348 Ems-XL Cardiac Electrophysiology SystemMennen Medical, Ltd. · 2007
- This deviceK134044 EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV · 2014
- Descendant · cites it directly · 4 of its ownK161245 EP-TRACER SystemCardio Tek, BV · 2016 · Recalled
- Descendant · 2 generations on · 3 of its ownK183266 EP-TRACER SystemSchwarzer Cardiotek GmbH · 2019 · Recalled
- Descendant · 3 generations on · 1 of its ownK220306 ECGenius SystemCath Vision Aps · 2022
- Descendant · 3 generations on · 0 of its ownK253088 OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd. · 2026
- Descendant · 4 generations on · 0 of its ownK223787 ECGenius SystemCath Vision Aps · 2023
Most influential descendants
Showing 5 of 5 · See all- K161245EP-TRACER SystemCardio Tek, BV · 2016 · cites it directly4descendants
- K183266EP-TRACER SystemSchwarzer Cardiotek GmbH · 2019 · 2 generations on3descendants
- K220306ECGenius SystemCath Vision Aps · 2022 · 3 generations on1descendant
- K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd. · 2026 · 3 generations on0descendants
- K223787ECGenius SystemCath Vision Aps · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862740 | Quinton Q.Cath | Quinton, Inc. | 1986 | — |
| −3 | K971570 | Epxpress System (Timberwolf Revision) /000391 | Quinton Electrophysiology Corp. | 1997 | — |
| −2 | K993414 | Prucka Engineering Inc. Cardiolab EP System,Version 4.2 | Prucka Engineering, Inc. | 2000 | — |
| −1 | K071348 | Ems-XL Cardiac Electrophysiology System | Mennen Medical, Ltd. | 2007 | — |
| 0 (this device) | K134044 | EP-Tracer System, EP-Tracer System, EP-Tracer System | Cardio Tek, BV | 2014 | — |
| +1 | K161245 | EP-TRACER System | Cardio Tek, BV | 2016 | 1 |
| +2 | K183266 | EP-TRACER System | Schwarzer Cardiotek GmbH | 2019 | 1 |
| +3 | K220306 | ECGenius System | Cath Vision Aps | 2022 | — |
| +3 | K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. | 2026 | — |
| +4 | K223787 | ECGenius System | Cath Vision Aps | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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? (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 |
|---|---|---|---|
| * | K071348 | Ems-XL Cardiac Electrophysiology SystemSummary page 1…The marketed device(s) to which substantial equivalence is claimed: . Mennen Medical EMS-XL Cardiac Electrophysiology System, K07 1348 Device The ER-Tracer system is a computerized electrophysiology measurement description system des… | 2007 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161245 | EP-TRACER System | 2016 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 13, 2017 | Class II | Z-2657-2017 | Software design | Software bug which allows parameters to be changed unintentionally during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 7.4 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K161245 (Cardio Tek, BV, 2016) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K071348.
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 Er-Tracer System is an electrophysiology measurement system used to
acquire, filter, digitize, amplf, display, and record signals obtained during
electrophysiological studies and related procedures.
The system allows the user to monitor, display and record the signals. The
system incorporates a stimulator intended to be used for diagnostic cardiac
stimulation during electrophysiological testing of the heart
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K134044 · printed Nov 4, 2026
Cite this page
510(k) Report. “K134044: EP-Tracer System, EP-Tracer System, EP-Tracer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K134044
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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