510(k) · Cleared
ClearedECGenius System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cath Vision Aps · DQK Computer, Diagnostic, Programmable
Cleared on May 3, 2022 as substantially equivalent to K183266 (Schwarzer Cardiotek GmbH, 2019) after a 90-day review. Its family tree reaches back 7 generations to 1986. 1 later device descends from it.
- Decided
- May 3, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K862740 (1986). 13 ancestors in all, the oldest K854196 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK862740 Quinton Q.CathQuinton, Inc. · 1986
- 6 generations backK971570 Epxpress System (Timberwolf Revision) /000391Quinton Electrophysiology Corp. · 1997
- 5 generations backK993414 Prucka Engineering Inc. Cardiolab EP System,Version 4.2Prucka Engineering, Inc. · 2000
- 4 generations backK071348 Ems-XL Cardiac Electrophysiology SystemMennen Medical, Ltd. · 2007
- 3 generations backK134044 EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV · 2014 · Recalled
- 2 generations backK161245 EP-TRACER SystemCardio Tek, BV · 2016 · Recalled
- 1 generation backK183266 EP-TRACER SystemSchwarzer Cardiotek GmbH · 2019 · Recalled
- This deviceK220306 ECGenius SystemCath Vision Aps · 2022
- Descendant · cites it directly · 0 of its ownK223787 ECGenius SystemCath Vision Aps · 2023
Most influential descendants
Showing 1 of 1 · See all- K223787ECGenius SystemCath Vision Aps · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K862740 | Quinton Q.Cath | Quinton, Inc. | 1986 | — |
| −6 | K971570 | Epxpress System (Timberwolf Revision) /000391 | Quinton Electrophysiology Corp. | 1997 | — |
| −5 | K993414 | Prucka Engineering Inc. Cardiolab EP System,Version 4.2 | Prucka Engineering, Inc. | 2000 | — |
| −4 | K071348 | Ems-XL Cardiac Electrophysiology System | Mennen Medical, Ltd. | 2007 | — |
| −3 | 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 |
| −1 | K183266 | EP-TRACER System | Schwarzer Cardiotek GmbH | 2019 | 1 |
| 0 (this device) | K220306 | ECGenius System | Cath Vision Aps | 2022 | — |
| +1 | 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 |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K183266 | EP-TRACER SystemSummary page 5…digitize, amplify, display, and record signals Schwarzer obtained during electrophysiological studies K183266 DQK CardioTek and related procedures. The system allows the EP-TRACER use… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223787 | ECGenius System | 2023 | 0 |
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 36 years and passes through 7 companies; a new generation was cleared every 3.2 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K223787 (Cath Vision Aps, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K183266.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 ECGenius™ System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record clinical data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party 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/K220306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220306: ECGenius System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220306
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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