# K991293: Epstim Electrophysiology Stimulator Control Program, Bloom Dtu-215 Electrophysiology Programmable Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Fischer Medical Technologies, Inc.
- Decided: May 5, 2000 after 386 days
- Product code: JOQ (Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only))
- Device class: 2
- Regulation: 21 CFR 870.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K173439: Bloom2 Programmable Electrophysiology Stimulator (2018), 0 descendants of its own

## Recalls of this device
- Jan 13, 2005 · Not classified · Z-0713-05: Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.

## Indications for use
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.

Source page: https://510kreport.com/device/K991293
Methodology: https://510kreport.com/methodology