PMA · Approved

Recalled · Class II · 2018

Ept-1000 Cardiac Ablation System

P920047PMAApproved Oct 28, 1994760-day reviewClass IIIRecalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific Corp · LPB Cardiac Ablation Percutaneous Catheter

Approved on Oct 28, 1994 through premarket approval, which rests on the device’s own clinical evidence after a 760-day review. It has been recalled 3 times.

Decided: Oct 28, 1994
Review: 760 days
Class: Class III
Product code: LPB
Recalls: 3

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

P920047 has 133 supplements since 1995: changes to the approved device, its labelling or its manufacturing, each approved separately.

PMA supplements approved per year

1995high 11 (2013) · low 0 (2000)2025

View FIG. 1 as a table

Year	Supplements approved
1995	4
1996	1
1997	3
1998	1
1999	3
2001	2
2002	2
2003	4
2004	3
2005	6
2006	3
2008	2
2009	2
2010	3
2011	7
2012	4
2013	11
2014	11
2015	10
2016	8
2017	10
2018	6
2019	7
2020	5
2021	2
2022	4
2023	3
2024	2
2025	4

FIG. 1 — Supplements to P920047, 1995–2025Source: FDA PMA database

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 LPB? 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

Get a 510(k) 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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 20, 2018	Class II	Z-0202-2019	—	Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.
Jul 14, 2009	Not classified	Z-0973-2011	Nonconforming Material/Component	Product malfunction causes inadvertent delivery of energy.
Feb 14, 2008	Not classified	Z-1617-2008	Nonconforming Material/Component	Package sterile barrier may be breached, compromising sterility.

No ancestor or descendant has a Class I recall.

How does its category compare?

All LPB devices

LPB Cardiac Ablation Percutaneous Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPB

15in 2025

2007high 85 (2014) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPB

Too few LPB 510(k)s in any year since 2007 to give a median.

Recalls per year · LPB

6in 2017

2007high 6 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPB

1,190in 2025

2007high 1,839 (2024) · low 61 (2007)2025

MAUDE reports naming product code LPB, 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	22	—	0	61
2008	20	—	4	75
2009	31	—	2	76
2010	45	—	1	63
2011	57	—	4	102
2012	38	—	0	248
2013	63	—	0	406
2014	85	—	1	799
2015	85	—	0	1,189
2016	54	—	0	1,010
2017	46	—	6	1,115
2018	35	—	0	975
2019	30	—	0	1,124
2020	33	—	0	1,182
2021	39	—	0	1,240
2022	25	—	0	1,336
2023	22	—	0	1,500
2024	18	—	0	1,839
2025	15	—	0	1,190
2026	8	—	0	—

https://510kreport.com/device/P920047 · printed Nov 6, 2026

Cite this page

510(k) Report. “P920047: Ept-1000 Cardiac Ablation System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P920047

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026