510(k) · Cleared
Recalled · 2005Epstim Electrophysiology Stimulator Control Program, Bloom Dtu-215 Electrophysiology Programmable Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fischer Medical Technologies, Inc. · JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Cleared on May 5, 2000 after a 386-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 once.
- Decided
- May 5, 2000
- Review
- 386 days
- Class
- Class II
- Product code
- JOQ
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK991293 Epstim Electrophysiology Stimulator Control Program, Bloom Dtu-215…Fischer Medical Technologies, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK173439 Bloom2 Programmable Electrophysiology StimulatorFischer Medical · 2018
Most influential descendants
Showing 1 of 1 · See all- K173439Bloom2 Programmable Electrophysiology StimulatorFischer Medical · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991293 | Epstim Electrophysiology Stimulator Control Program, Bloom Dtu-215… | Fischer Medical Technologies, Inc. | 2000 | — |
| +1 | K173439 | Bloom2 Programmable Electrophysiology Stimulator | Fischer Medical | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| K173439 | Bloom2 Programmable Electrophysiology Stimulator | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 13, 2005 | Not classified | Z-0713-05 | Other | Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K173439 (Fischer Medical, 2018) 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 DTU-215 Programmable Electrophysiology Stimulator with the EPStim Electrophysiology Stimulator Control Program is indicated for patients that are candidates for electrophysiology studies for the diagnosis, and the planning of treatment for super-ventricular, ventricular tachyarrhythmias, conduction disorders, syncopy and other miscellaneous arrhythmias. The EPstim is intended for assisting a physician in performing an electrophysiology study by…
Read the full statement (116 words)
The DTU-215 Programmable Electrophysiology Stimulator with the EPStim Electrophysiology Stimulator Control Program is indicated for patients that are candidates for electrophysiology studies for the diagnosis, and the planning of treatment for super-ventricular, ventricular tachyarrhythmias, conduction disorders, syncopy and other miscellaneous arrhythmias.
The EPstim is intended for assisting a physician in performing an electrophysiology study by providing automated control of the DTU-215 Programmable Stimulator. The system provides for compilation, storage and rapid execution of a customized series of stimulator commands (stimulation protocols), and automatic determination of capture during cardiac electrophysiological testing.
The DTU-215 Programmable Stimulator is intended for use in the electrophysiology laboratory during electrophysiology testing under the direction of qualified personnel trained to administer electrophysiological procedures.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991293: Epstim Electrophysiology Stimulator Control Program, Bloom Dtu-215 Electrophysiology Programmable Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991293
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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