510(k) · Cleared
ClearedEPS320 Cardiac Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micropace Pty, Ltd. · JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Cleared on Jan 24, 2002 as substantially equivalent to K854196 (Digital Cardiovascular Instruments, Inc., 1986) after a 227-day review. Its family tree reaches back 1 generation to 1986. 11 later devices descend from it.
- Decided
- Jan 24, 2002
- Review
- 227 days
- Class
- Class II
- Product code
- JOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854196 (1986). 11 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK854196 Dci Model EP-2 Clinical StimulatorDigital Cardiovascular Instruments, Inc. · 1986
- This deviceK011826 EPS320 Cardiac StimulatorMicropace Pty, Ltd. · 2002
- Descendant · cites it directly · 7 of its ownK071348 Ems-XL Cardiac Electrophysiology SystemMennen Medical, Ltd. · 2007
- Descendant · 2 generations on · 5 of its ownK134044 EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV · 2014 · Recalled
- Descendant · 3 generations on · 4 of its ownK161245 EP-TRACER SystemCardio Tek, BV · 2016 · Recalled
- Descendant · 4 generations on · 3 of its ownK183266 EP-TRACER SystemSchwarzer Cardiotek GmbH · 2019 · Recalled
- Descendant · 5 generations on · 1 of its ownK220306 ECGenius SystemCath Vision Aps · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K071348Ems-XL Cardiac Electrophysiology SystemMennen Medical, Ltd. · 2007 · cites it directly7descendants
- K134044EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV · 2014 · 2 generations on5descendants
- K161245EP-TRACER SystemCardio Tek, BV · 2016 · 3 generations on4descendants
- K183266EP-TRACER SystemSchwarzer Cardiotek GmbH · 2019 · 4 generations on3descendants
- K220306ECGenius SystemCath Vision Aps · 2022 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854196 | Dci Model EP-2 Clinical Stimulator | Digital Cardiovascular Instruments, Inc. | 1986 | — |
| 0 (this device) | K011826 | EPS320 Cardiac Stimulator | Micropace Pty, Ltd. | 2002 | — |
| +1 | K071348 | Ems-XL Cardiac Electrophysiology System | Mennen Medical, Ltd. | 2007 | — |
| +2 | K134044 | EP-Tracer System, EP-Tracer System, EP-Tracer System | Cardio Tek, BV | 2014 | 1 |
| +3 | K161245 | EP-TRACER System | Cardio Tek, BV | 2016 | 1 |
| +4 | K183266 | EP-TRACER System | Schwarzer Cardiotek GmbH | 2019 | 1 |
| +5 | K220306 | ECGenius System | Cath Vision Aps | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 JOQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K854196 | Dci Model EP-2 Clinical StimulatorSummary page 3…e) Micropace model EPS320 A. Manufacturer Digital Cardiovascular Instruments, Inc. Berkeley, CA Micropace Pty Ltd. Campsie, N.S.W Australia B. FDA Concurrence Yes (K854196/B) Pending 1. Isolated Stimulus Channels 2 2 2. Pulse Amplitude — larger) Range . 0.1-20 mA (2500 Q load) 0.1 to 25mA into… | 1986 |
What descends from it? (11)
See all 114 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?
- Its one ancestor has no recall.
- Of its descendants, K071348 (Mennen Medical, Ltd., 2007) has gone furthest, with 7 descendants of its own.
How does its category compare?
All JOQ devicesJOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOQ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · JOQ
Too few JOQ 510(k)s in any year since 2007 to give a median.
Recalls per year · JOQ
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOQ
5in 2025
MAUDE reports naming product code JOQ, 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 | 2 | — | 0 | 8 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EPS320 Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation during electrophysiological testing of the human heart.
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/K011826 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011826: EPS320 Cardiac Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011826
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026