510(k) · Cleared
ClearedOneStim-DUO Cardiac Stimulator (MP5003-4CO)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micropace Pty, Ltd. · DQK Computer, Diagnostic, Programmable
Cleared on Jun 12, 2026 as substantially equivalent to K183266 (Schwarzer Cardiotek GmbH, 2019) and 1 other predicate after a 262-day review. Its family tree reaches back 7 generations to 1986.
- Decided
- Jun 12, 2026
- Review
- 262 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K862740 (1986). 13 ancestors in all, the oldest K854196 (1986). No later device cites it as a predicate yet.
- 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 deviceK253088 OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd. · 2026
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) | 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 |
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 |
|---|---|---|---|
| * | K183266 | EP-TRACER System Our reading of the summary gave K083266, FDA’s number for Gore Bio-a Fistula Plug (W. L. Gore & Associates, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “EP-Tracer System”. | 2019 |
| * | K011826 | EPS320 Cardiac StimulatorSummary page 5…Programmable Product Codes DQK, JOQ Predicate Devices K083266 EP-Tracer System DQK K011826 EPS320 Cardiac Stimulator JOQ Device Description Summary The OneStim Cardiac Stimulator is an updated p… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 40 years and passes through 7 companies; a new generation was cleared every 6.6 years on median.
- 3 of the 13 ancestors have a recall of any class.
- 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. 2026, 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 OneStim is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record cardiac electrical signals combined with a programmable diagnostic cardiac stimulator intended to be used for testing of the heart during cardiac electrophysiological studies and related procedures in hospital facilities.
The OneStim indicated for adult and pediatric population in the management of cardiac arrhythmias and conduction disorders.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253088: OneStim-DUO Cardiac Stimulator (MP5003-4CO).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253088
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026