510(k) · Cleared
ClearedEms-XL Cardiac Electrophysiology System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mennen Medical, Ltd. · DQK Computer, Diagnostic, Programmable
Cleared on Sep 7, 2007 as substantially equivalent to K993414 (Prucka Engineering, Inc., 2000) and 1 other predicate after a 116-day review. Its family tree reaches back 3 generations to 1986. 7 later devices descend from it.
- Decided
- Sep 7, 2007
- Review
- 116 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K862740 (1986). 9 ancestors in all, the oldest K854196 (1986). 7 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK862740 Quinton Q.CathQuinton, Inc. · 1986
- 2 generations backK971570 Epxpress System (Timberwolf Revision) /000391Quinton Electrophysiology Corp. · 1997
- 1 generation backK993414 Prucka Engineering Inc. Cardiolab EP System,Version 4.2Prucka Engineering, Inc. · 2000
- This deviceK071348 Ems-XL Cardiac Electrophysiology SystemMennen Medical, Ltd. · 2007
- Descendant · cites it directly · 5 of its ownK134044 EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV · 2014 · Recalled
- Descendant · 2 generations on · 4 of its ownK161245 EP-TRACER SystemCardio Tek, BV · 2016 · Recalled
- Descendant · 3 generations on · 3 of its ownK183266 EP-TRACER SystemSchwarzer Cardiotek GmbH · 2019 · Recalled
- Descendant · 4 generations on · 1 of its ownK220306 ECGenius SystemCath Vision Aps · 2022
- Descendant · 4 generations on · 0 of its ownK253088 OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K134044EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV · 2014 · cites it directly5descendants
- K161245EP-TRACER SystemCardio Tek, BV · 2016 · 2 generations on4descendants
- K183266EP-TRACER SystemSchwarzer Cardiotek GmbH · 2019 · 3 generations on3descendants
- K220306ECGenius SystemCath Vision Aps · 2022 · 4 generations on1descendant
- K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862740 | Quinton Q.Cath | Quinton, Inc. | 1986 | — |
| −2 | K971570 | Epxpress System (Timberwolf Revision) /000391 | Quinton Electrophysiology Corp. | 1997 | — |
| −1 | K993414 | Prucka Engineering Inc. Cardiolab EP System,Version 4.2 | Prucka Engineering, Inc. | 2000 | — |
| 0 (this device) | K071348 | Ems-XL Cardiac Electrophysiology System | Mennen Medical, Ltd. | 2007 | — |
| +1 | K134044 | EP-Tracer System, EP-Tracer System, EP-Tracer System | Cardio Tek, BV | 2014 | 1 |
| +2 | K161245 | EP-TRACER System | Cardio Tek, BV | 2016 | 1 |
| +3 | K183266 | EP-TRACER System | Schwarzer Cardiotek GmbH | 2019 | 1 |
| +4 | K220306 | ECGenius System | Cath Vision Aps | 2022 | — |
| +4 | K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. | 2026 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K993414 | Prucka Engineering Inc. Cardiolab EP System,Version 4.2Summary page 1…Class II 7. Product Code DQK 8. Predicated Devices: Substantial Equivalence is claimed to the following devices: - K993414 (4 July 2000) - Cardiolab EP system. Prucka Engineering, Inc - K011826 (24 Jan 2002)- Micropace model EPS 320. Micropace Pty L… | 2000 |
| * | K011826 | EPS320 Cardiac StimulatorSummary page 1…8. Predicated Devices: Substantial Equivalence is claimed to the following devices: - K993414 (4 July 2000) - Cardiolab EP system. Prucka Engineering, Inc - K011826 (24 Jan 2002)- Micropace model EPS 320. Micropace Pty Ltd.… | 2002 |
What descends from it? (7)
2 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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K134044 (Cardio Tek, BV, 2014) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K993414.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
EMS-XL is indicated to acquire, filter, digitize, amplify, display and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals and pressure recordings. Physiological parameters such as the diastolic, systolic and mean blood pressure, heart rate and cycle length are derived from the signal data, displayed…
Read the full statement (146 words)
EMS-XL is indicated to acquire, filter, digitize, amplify, display and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals and pressure recordings. Physiological parameters such as the diastolic, systolic and mean blood pressure, heart rate and cycle length are derived from the signal data, displayed and recorded.
The system allows the user to monitor, display and record the signal data.
The system allows the user to monitor the acquisition data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. The system may display and record data received from other medical devices typically used during these procedures, such as Ablation RF generators. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the human heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071348 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071348: Ems-XL Cardiac Electrophysiology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071348
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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