510(k) · Cleared
ClearedExternal Counterpulsation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vamed Medical Instrument Co., Ltd. · DRN Device, Counter-Pulsating, External
Cleared on Sep 10, 2019 as substantially equivalent to K130439 (Chongqing Psk Sci-Tech Development Co., Ltd., 2013) and 1 other predicate after a 176-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Sep 10, 2019
- Review
- 176 days
- Class
- Class II
- Product code
- DRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K980937 (2000). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK980937 Nicore Model Esp -1Nicore Equipment & Leasing, Inc. · 2000
- 3 generations backK042413 Acs Model NCP-2Applied Cardiac Systems · 2004
- 2 generations backK152115 Renew NCP-5 External Counterpulsation SystemStage 2 Innovations · 2015
- 1 generation backK173483 Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLC · 2018
- This deviceK190683 External Counterpulsation SystemVamed Medical Instrument Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK202108 External Counterpulsation System, SoulaireVamed Medical Instrument Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K202108External Counterpulsation System, SoulaireVamed Medical Instrument Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K980937 | Nicore Model Esp -1 | Nicore Equipment & Leasing, Inc. | 2000 | — |
| −3 | K042413 | Acs Model NCP-2 | Applied Cardiac Systems | 2004 | — |
| −2 | K152115 | Renew NCP-5 External Counterpulsation System | Stage 2 Innovations | 2015 | — |
| −1 | K173483 | Pure Flow External Counter-Pulsation Device | Xtreem Pulse, LLC | 2018 | — |
| 0 (this device) | K190683 | External Counterpulsation System | Vamed Medical Instrument Co., Ltd. | 2019 | — |
| +1 | K202108 | External Counterpulsation System, Soulaire | Vamed Medical Instrument Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 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? (2)
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 |
|---|---|---|---|
| * | K130439 | External Counterpulsation Device with SP02 MornitoringSummary page 5…Regulation Class: 2 3. Predicate Device Information 1) Primary Predicate Device Sponsor: Chongqing Psk Sci-tech Devolpment Co., Ltd. 510K number: K130439 Trade/Device Name: External Counterpulsation Device with SPO2 Monitoring Model: P-ECP/TI Regulation Number: 21 CFR 870.5225… | 2013 |
| * | K173483 | Pure Flow External Counter-Pulsation DeviceSummary page 5…Sponsor: Xtreem Pulse, LLC Device Name: External Counter-Pulsation Device Model: PureFlow Classification Name: External counter-pulsating device 510(k) number: K173483 Review Panel: Cardiovascular Product Code: DRN Regulation Number: 21 CFR 870.5225 4. Device Description ECP-MC3 is… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202108 | External Counterpulsation System, Soulaire | 2020 | 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?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K202108 (Vamed Medical Instrument Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K130439.
How does its category compare?
All DRN devicesDRN Device, Counter-Pulsating, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 ECP-MC3 device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, and increased blood flow. It is intended for use under the oversight of a healthcare professional.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190683: External Counterpulsation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190683
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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