510(k) · Cleared
ClearedBloom2 Programmable Electrophysiology Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fischer Medical · JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Cleared on Mar 29, 2018 as substantially equivalent to K072200 (Micropace Pty, Ltd., 2007) and 1 other predicate after a 146-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Mar 29, 2018
- Review
- 146 days
- Class
- Class II
- Product code
- JOQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K854196 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK854196 Dci Model EP-2 Clinical StimulatorDigital Cardiovascular Instruments, Inc. · 1986
- 2 generations backK011826 EPS320 Cardiac StimulatorMicropace Pty, Ltd. · 2002
- 1 generation backK072200 StimlabMicropace Pty, Ltd. · 2007
- This deviceK173439 Bloom2 Programmable Electrophysiology StimulatorFischer Medical · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K854196 | Dci Model EP-2 Clinical Stimulator | Digital Cardiovascular Instruments, Inc. | 1986 | — |
| −2 | K011826 | EPS320 Cardiac Stimulator | Micropace Pty, Ltd. | 2002 | — |
| −1 | K072200 | Stimlab | Micropace Pty, Ltd. | 2007 | — |
| 0 (this device) | K173439 | Bloom2 Programmable Electrophysiology Stimulator | Fischer Medical | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
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
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072200 | StimlabSummary page 4…erator, Pulse, Pacemaker, External Product code: JOQ name: Programmable Predicate K072200, StimLab™/EPS320™ Electrophysiology Stimulator System devices: & Accessories and K991293, EPStim Bloom DTU-215B™… | 2007 |
| * | K991293 | Epstim Electrophysiology Stimulator Control Program, Bloom Dtu-215 Electrophysiology…Summary page 4…Product code: JOQ name: Programmable Predicate K072200, StimLab™/EPS320™ Electrophysiology Stimulator System devices: & Accessories and K991293, EPStim Bloom DTU-215B™ Electrophysiology Stimulator System & Accessories Device description: The Bloom2™ Card… | 2000 |
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?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2018, this device’s year, is highlighted.
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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173439: Bloom2 Programmable Electrophysiology Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173439
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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