510(k) Report

510(k) · Cleared

Cleared

EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04

K092913510(k) SpecialCleared Oct 16, 200924-day reviewClass II21 CFR 870.1750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ep Medsystems · JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

Cleared on Oct 16, 2009 as substantially equivalent to K040207 (Ep Medsystems, 2004) after a 24-day review. Its family tree reaches back 1 generation to 2004.

Decided
Oct 16, 2009
Review
24 days
Class
Class II
Product code
JOQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K040207 (2004). No later device cites it as a predicate yet.

K040207 · EP-4 Clinical Stimulator · Ep Medsystems · 2004 · recalled200020022004200620082010
K040207 · EP-4 Clinical Stimulator · Ep Medsystems · 2004 · recalled0
  1. Root · 1 generation backK040207 EP-4 Clinical StimulatorEp Medsystems · 2004 · Recalled
  2. This deviceK092913 EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04Ep Medsystems · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K040207EP-4 Clinical StimulatorEp Medsystems20042
0 (this device)K092913EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04Ep Medsystems2009—
FIG. 1 — Lineage of K092913, 2004–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K040207EP-4 Clinical Stimulator
Summary page 1
…External Programmable Pacemaker Pulse Generator Name Classification Name JOQ, Class II,21 CFR 870.1750 Predicate Device EP-4 TM Clinical Stimulator (K040207) Device Description The EP-4 Cardiac Stimulator consists of a touch-screen computer, an AC-powered stimulation module, which pro…
Ep Medsystems20042

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?

  • Its one ancestor has a recall.

How does its category compare?

All JOQ devices

JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · JOQ

1in 2018

2007: 22009: 12018: 1
2007high 2 (2007) · low 0 (2008)2026

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

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JOQ

5in 2025

2007: 82008: 22009: 32010: 112011: 92012: 252013: 12014: 32017: 42018: 32019: 42020: 22021: 22022: 42023: 102024: 82025: 5
2007high 25 (2012) · low 0 (2015)2025

MAUDE reports naming product code JOQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—08
20080—02
20091—13
20100—011
20110—09
20120—025
20130—01
20140—03
20150—00
20160—00
20170—04
20181—03
20190—04
20200—02
20210—02
20220—04
20230—010
20240—08
20250—05
20260—0—

What is it indicated for?

The EP-4 Cardiac Stimulator is indicated for use during clinical cardiac electrophysiology procedures.

Indications for use as stated in the FDA summary.

More from Ep Medsystems

12 FDA decisions under this applicant name. See the company

  • K073709Modification to Viewmate SystemEp Medsystems · 2008
  • K071028Viewmate SystemEp Medsystems · 2007
  • K070706EP-WorkmateEp Medsystems · 20071 recall
  • K063113EP-WorkmateEp Medsystems · 2006
  • K041442EP-4 Clinical StimutatorEp Medsystems · 20041 recall

Recent decisions in JOQ

The JOQ category page

  • K173439Bloom2 Programmable Electrophysiology StimulatorFischer Medical · 2018
  • K072200StimlabMicropace Pty, Ltd. · 2007
  • K070743Z6 StimulatorSt Cardio Technologies, LLC · 2007
  • K041442EP-4 Clinical StimutatorEp Medsystems · 20041 recall
  • K040207EP-4 Clinical StimulatorEp Medsystems · 20042 recalls

https://510kreport.com/device/K092913 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092913: EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092913

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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