PMA · Approved
ApprovedExternal Pulse Generator Model 2A, Tapscope 500 Series Esophageal Stethoscope and Pacing Catheter, Tapscope 210 Esophagr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiocommand, Inc. · LPA System, Esophageal Pacing
Approved on Aug 27, 2004 through premarket approval, which rests on the device’s own clinical evidence after an 84-day review.
- Decided
- Aug 27, 2004
- Review
- 84 days
- Class
- Class III
- Product code
- LPA
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPA? 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
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.
How does its category compare?
All LPA devicesLPA System, Esophageal Pacing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPA
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · LPA
Too few LPA 510(k)s in any year since 2007 to give a median.
Recalls per year · LPA
2in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPA
No MAUDE report names LPA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 2 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 3 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P840002/S012 · printed Nov 6, 2026
Cite this page
510(k) Report. “P840002/S012: External Pulse Generator Model 2A, Tapscope 500 Series Esophageal Stethoscope and Pacing Catheter, Tapscope 210 Esophagr.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P840002/S012
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026