510(k) · Cleared

Cleared

Ecp Health System, Model 2005

K052611510(k) TraditionalCleared Apr 26, 2006216-day reviewClass II21 CFR 870.5225

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

Ecp Health, Inc. · DRN Device, Counter-Pulsating, External

Cleared on Apr 26, 2006 as substantially equivalent to K030587 (S-Tct Health, Inc., 2003) after a 216-day review. Its family tree reaches back 2 generations to 1995.

Decided: Apr 26, 2006
Review: 216 days
Class: Class II
Product code: DRN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K940264 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK940264 Vasogenics Eecp-MC2Vasogenics, Inc. · 1995
1 generation backK030587 External Counterpulsation (Ecp) Model US-EcpS-Tct Health, Inc. · 2003
This deviceK052611 Ecp Health System, Model 2005Ecp Health, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K940264	Vasogenics Eecp-MC2	Vasogenics, Inc.	1995	—
−1	K030587	External Counterpulsation (Ecp) Model US-Ecp	S-Tct Health, Inc.	2003	—
0 (this device)	K052611	Ecp Health System, Model 2005	Ecp Health, Inc.	2006	—

FIG. 1 — Lineage of K052611, 1995–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DRN device

#1 K250756 Pression Wave PRO External Counter-Pulsation…score 10.9 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K030587	External Counterpulsation (Ecp) Model US-Ecp Summary page 1 …equivalent to S-TCT Health External Counterpulsation Device (FDA granted 5 10O(k) clearance on May 30, 2003 - K03 0587) 6. Device Description: ECP Health System Model 2005 is a positive and negative pressure integrated…	S-Tct Health, Inc.	2003	—

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 11 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All DRN devices

DRN Device, Counter-Pulsating, External: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRN

1in 2025

2007high 2 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRN

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

Recalls per year · DRN

1in 2009

2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DRN

1in 2024

2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code DRN, 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	2
2008	1	—	0	0
2009	1	—	1	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	1	—	0	0
2014	0	—	0	0
2015	1	—	0	0
2016	0	—	0	1
2017	0	—	0	0
2018	1	—	0	0
2019	1	—	0	0
2020	2	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	1
2025	1	—	0	0
2026	0	—	0	—

What is it indicated for?

The intended use of the ECP Health System Model 2005 is for the treatment of patients with:

(1). Stable or unstable angina pectoris.

(2). Acute myocardial infarction

(3). Cardiogenic shock

(4). Congestive heart failure

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052611 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052611: Ecp Health System, Model 2005.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052611

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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