510(k) · Cleared
Recalled · 2009EP-4 Clinical Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ep Medsystems · JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Cleared on Feb 27, 2004 after a 28-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Feb 27, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- JOQ
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK040207 EP-4 Clinical StimulatorEp Medsystems · 2004
- Descendant · cites it directly · 0 of its ownK092913 EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04Ep Medsystems · 2009
Most influential descendants
Showing 1 of 1 · See all- K092913EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04Ep Medsystems · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040207 | EP-4 Clinical Stimulator | Ep Medsystems | 2004 | — |
| +1 | K092913 | EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04 | Ep Medsystems | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K092913 | EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04 | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 23, 2009 | Not classified | Z-1422-2009 | Device Design | Non-compliance with IEC Standard 60601-1 Clause 57.6 relative to fusing of AC input line. The neutral line is not fused. The hot line in fused. Clause 57.6 calls for both lines to be fused. |
| Apr 4, 2006 | Not classified | Z-0914-06 | Other | Under certain circumstances the device may exhibit the following behaviors: 1)-Initiation of a rapid stimulation train without command, when the device is in use in conjuction with an electrosurgical unit or RF ablation unit-2)-Presence… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092913 (Ep Medsystems, 2009) has gone furthest, with 0 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 EP-4 Clinical Stimulator is intended to be used for diagnostic electrical Stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachyarrhymias, and measurements of electrical conductions,
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040207: EP-4 Clinical Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040207
Report an extraction error
Are you the manufacturer?
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