510(k) · Cleared

Cleared

External Counterpulsation (Ecp) Model US-Ecp

K030587510(k) TraditionalCleared May 30, 200394-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

S-Tct Health, Inc. · DRN Device, Counter-Pulsating, External

Cleared on May 30, 2003 as substantially equivalent to K940264 (Vasogenics, Inc., 1995) after a 94-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: May 30, 2003
Review: 94 days
Class: Class II
Product code: DRN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K940264 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK940264 Vasogenics Eecp-MC2Vasogenics, Inc. · 1995
This deviceK030587 External Counterpulsation (Ecp) Model US-EcpS-Tct Health, Inc. · 2003
Descendant · cites it directly · 0 of its ownK052611 Ecp Health System, Model 2005Ecp Health, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all

K052611Ecp Health System, Model 2005Ecp Health, Inc. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K030587, 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
*	K940264	Vasogenics Eecp-MC2 Summary page 1 …cation name: Device, Counterpulsating, External 5. Predicate Device: The US-ECP is substantially equivalent to: Vasomedical Model EECPB-MC2 (K940264), for which clearance was granted February 23, 1995. 6. Description of The US-ECP is a painless, n…	Vasogenics, Inc.	1995	—

Also cleared against K940264: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K052611	Ecp Health System, Model 2005	Ecp Health, Inc.	2006	0

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?

Its one ancestor has no recall.
Of its descendants, K052611 (Ecp Health, Inc., 2006) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K940264.

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?

S-TCT Health, Inc.’s US-ECP Model IV is a non-invasive external counterpulsating device intended for use in the treatment of patients with stable angina pectoris, acute myocardial infarction and cardiogenic shock.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030587 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030587: External Counterpulsation (Ecp) Model US-Ecp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030587

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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