510(k) · Cleared
ClearedDci Model EP-2 Clinical Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digital Cardiovascular Instruments, Inc. · DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Cleared on May 1, 1986 after a 198-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- May 1, 1986
- Review
- 198 days
- Class
- Class II
- Product code
- DRO
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK854196 Dci Model EP-2 Clinical StimulatorDigital Cardiovascular Instruments, Inc. · 1986
- Descendant · cites it directly · 11 of its ownK011826 EPS320 Cardiac StimulatorMicropace Pty, Ltd. · 2002
- Descendant · 2 generations on · 7 of its ownK071348 Ems-XL Cardiac Electrophysiology SystemMennen Medical, Ltd. · 2007
- Descendant · 3 generations on · 5 of its ownK134044 EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV · 2014 · Recalled
- Descendant · 4 generations on · 4 of its ownK161245 EP-TRACER SystemCardio Tek, BV · 2016 · Recalled
- Descendant · 5 generations on · 3 of its ownK183266 EP-TRACER SystemSchwarzer Cardiotek GmbH · 2019 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K011826EPS320 Cardiac StimulatorMicropace Pty, Ltd. · 2002 · cites it directly11descendants
- K071348Ems-XL Cardiac Electrophysiology SystemMennen Medical, Ltd. · 2007 · 2 generations on7descendants
- K134044EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV · 2014 · 3 generations on5descendants
- K161245EP-TRACER SystemCardio Tek, BV · 2016 · 4 generations on4descendants
- K183266EP-TRACER SystemSchwarzer Cardiotek GmbH · 2019 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K854196 | Dci Model EP-2 Clinical Stimulator | Digital Cardiovascular Instruments, Inc. | 1986 | — |
| +1 | K011826 | EPS320 Cardiac Stimulator | Micropace Pty, Ltd. | 2002 | — |
| +2 | K071348 | Ems-XL Cardiac Electrophysiology System | Mennen Medical, Ltd. | 2007 | — |
| +3 | K134044 | EP-Tracer System, EP-Tracer System, EP-Tracer System | Cardio Tek, BV | 2014 | 1 |
| +4 | K161245 | EP-TRACER System | Cardio Tek, BV | 2016 | 1 |
| +5 | K183266 | EP-TRACER System | Schwarzer Cardiotek GmbH | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRO? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011826 | EPS320 Cardiac Stimulator | 2002 | 11 |
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?
- Of its descendants, K011826 (Micropace Pty, Ltd., 2002) has gone furthest, with 11 descendants of its own.
How does its category compare?
All DRO devicesDRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRO
FDA has decided no DRO device since 2007.
Median 510(k) review, days · DRO
Too few DRO 510(k)s in any year since 2007 to give a median.
Recalls per year · DRO
12in 2020
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DRO
2in 2025
MAUDE reports naming product code DRO, 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 | 0 | — | 0 | 7 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 1 | 7 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 4 (4) | 2 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 49 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 64 |
| 2019 | 0 | — | 0 | 93 |
| 2020 | 0 | — | 12 | 19 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K854196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K854196: Dci Model EP-2 Clinical Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854196
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026