510(k) · Cleared
ClearedExternal Counterpulsation Device with SP02 Mornitoring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chongqing Psk Sci-Tech Development Co., Ltd. · DRN Device, Counter-Pulsating, External
Cleared on Dec 12, 2013 after a 294-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Dec 12, 2013
- Review
- 294 days
- Class
- Class II
- Product code
- DRN
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK130439 External Counterpulsation Device with SP02 MornitoringChongqing Psk Sci-Tech Development Co., Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK190683 External Counterpulsation SystemVamed Medical Instrument Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK202108 External Counterpulsation System, SoulaireVamed Medical Instrument Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK191955 Enhanced External Counter Pulsation Device Plus Omay-AOmay (Guangzhou)Med Technologies Co., Ltd. · 2020
Most influential descendants
Showing 3 of 3 · See all- K190683External Counterpulsation SystemVamed Medical Instrument Co., Ltd. · 2019 · cites it directly1descendant
- K202108External Counterpulsation System, SoulaireVamed Medical Instrument Co., Ltd. · 2020 · 2 generations on0descendants
- K191955Enhanced External Counter Pulsation Device Plus Omay-AOmay (Guangzhou)Med Technologies Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K130439 | External Counterpulsation Device with SP02 Mornitoring | Chongqing Psk Sci-Tech Development Co., Ltd. | 2013 | — |
| +1 | K190683 | External Counterpulsation System | Vamed Medical Instrument Co., Ltd. | 2019 | — |
| +2 | K202108 | External Counterpulsation System, Soulaire | Vamed Medical Instrument Co., Ltd. | 2020 | — |
| +1 | K191955 | Enhanced External Counter Pulsation Device Plus Omay-A | Omay (Guangzhou)Med Technologies Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K190683 (Vamed Medical Instrument Co., Ltd., 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DRN devicesDRN Device, Counter-Pulsating, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 intended use of the ECP device is to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock and acute myocardial infarction.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K130439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130439: External Counterpulsation Device with SP02 Mornitoring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130439
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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