# K173439: Bloom2 Programmable Electrophysiology Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Fischer Medical
- Decided: Mar 29, 2018 after 146 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K854196 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072200: Stimlab, Micropace Pty, Ltd. (2007) Summary page 4.
- K991293: Epstim Electrophysiology Stimulator Control Program, Bloom Dtu-215 Electrophysiology Programmable Stimulator, Fischer Medical Technologies, Inc. (2000) Summary page 4.

## Indications for use
The Bloom2 is intended for use in the electrophysiology laboratory during electrophysiology testing, under the direction of qualified personnel trained to administer electrophysiology procedures. The Bloom2 Cardiac Stimulator System is a programmable, electrical, pulse generator intended to provide diagnostic, electrical, cardiac stimulation. It is not intended for use, nor should it be used, as an external pacemaker for long-term support of the pacemaker dependent patient.

Source page: https://510kreport.com/device/K173439
Methodology: https://510kreport.com/methodology