510(k) · Cleared
ClearedPression Wave PRO External Counter-Pulsation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pression, Inc. · DRN Device, Counter-Pulsating, External
Cleared on Dec 22, 2025 as substantially equivalent to K042413 (Applied Cardiac Systems, 2004) after a 285-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Dec 22, 2025
- Review
- 285 days
- Class
- Class II
- Product code
- DRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980937 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980937 | Nicore Model Esp -1 | Nicore Equipment & Leasing, Inc. | 2000 | — |
| −1 | K042413 | Acs Model NCP-2 | Applied Cardiac Systems | 2004 | — |
| 0 (this device) | K250756 | Pression Wave PRO External Counter-Pulsation System | Pression, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
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 K202108 External Counterpulsation System, Soulairescore 1.1 · 5 generations · no Class I recall
- #2 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K042413 | Acs Model NCP-2Summary page 5…ice Manufacturer: Applied Cardiac Systems, Inc. (ACS) Trade Name: ACS Model NCP-2 External Counterpulsation System 510(k) No.: K042413 CONFIDENTIAL Page 1 of 9 Pres… | 2004 |
| † | K190683 | External Counterpulsation System | 2019 |
| † | K022107 | Cardiassist Counterpulsation System, Model Mark 3000 | 2002 |
| † | K152115 | Renew NCP-5 External Counterpulsation System | 2015 |
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 25 years and passes through 3 companies; a new generation was cleared every 21.0 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K042413.
How does its category compare?
All DRN devicesDRN Device, Counter-Pulsating, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DRN
1in 2025
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRN
1in 2024
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 Pression Wave PRO External Counter-Pulsation System is indicated for the treatment of chronic stable angina (CSA) that is refractory to optimal anti-anginal medical therapy and without options for revascularization in adult patients that weigh greater than 40kg. In addition, it is intended for use in healthy adult patients to provide improvement in vasodilation, increased VO2, and increased blood flow. It is intended for use under the supervision of a healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250756 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250756: Pression Wave PRO External Counter-Pulsation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250756
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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