510(k) · Cleared
ClearedExternal Counterpulsation System, Soulaire
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 Aug 28, 2020 as substantially equivalent to K190683 (Vamed Medical Instrument Co., Ltd., 2019) after a 29-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Aug 28, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- DRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K980937 (2000). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK980937 Nicore Model Esp -1Nicore Equipment & Leasing, Inc. · 2000
- 4 generations backK042413 Acs Model NCP-2Applied Cardiac Systems · 2004
- 3 generations backK152115 Renew NCP-5 External Counterpulsation SystemStage 2 Innovations · 2015
- 2 generations backK173483 Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLC · 2018
- 1 generation backK190683 External Counterpulsation SystemVamed Medical Instrument Co., Ltd. · 2019
- This deviceK202108 External Counterpulsation System, SoulaireVamed Medical Instrument Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K980937 | Nicore Model Esp -1 | Nicore Equipment & Leasing, Inc. | 2000 | — |
| −4 | K042413 | Acs Model NCP-2 | Applied Cardiac Systems | 2004 | — |
| −3 | K152115 | Renew NCP-5 External Counterpulsation System | Stage 2 Innovations | 2015 | — |
| −2 | K173483 | Pure Flow External Counter-Pulsation Device | Xtreem Pulse, LLC | 2018 | — |
| −1 | K190683 | External Counterpulsation System | Vamed Medical Instrument Co., Ltd. | 2019 | — |
| 0 (this device) | 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 |
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 10.8 · 2 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 |
|---|---|---|---|
| * | K190683 | External Counterpulsation SystemSummary page 4…ulation Class: 2 3 Legally marketed device (predicate device) Information Common Name: External Counterpulsation System Model: ECP-MC3 510(K) Number: K190683 Classification Name: External counter-pulsating device Review Panel: Cardiovascular Product Code: DRN Regulat… | 2019 |
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 20 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All DRN devicesDRN Device, Counter-Pulsating, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 External Counterpulsation System, Soulaire 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 as stated in the FDA summary.
https://510kreport.com/device/K202108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202108: External Counterpulsation System, Soulaire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202108
Report an extraction error
Are you the manufacturer?
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