510(k) · Cleared
ClearedEnhanced External Counter Pulsation Device Plus Omay-A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omay (Guangzhou)Med Technologies Co., Ltd. · DRN Device, Counter-Pulsating, External
Cleared on Aug 5, 2020 as substantially equivalent to K130439 (Chongqing Psk Sci-Tech Development Co., Ltd., 2013) after a 380-day review. Its family tree reaches back 1 generation to 2013.
- Decided
- Aug 5, 2020
- Review
- 380 days
- Class
- Class II
- Product code
- DRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K130439 (2013). No later device cites it as a predicate yet.
- Root · 1 generation backK130439 External Counterpulsation Device with SP02 MornitoringChongqing Psk Sci-Tech Development Co., Ltd. · 2013
- This deviceK191955 Enhanced External Counter Pulsation Device Plus Omay-AOmay (Guangzhou)Med Technologies Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K130439 | External Counterpulsation Device with SP02 Mornitoring | Chongqing Psk Sci-Tech Development Co., Ltd. | 2013 | — |
| 0 (this device) | K191955 | Enhanced External Counter Pulsation Device Plus Omay-A | Omay (Guangzhou)Med Technologies Co., Ltd. | 2020 | — |
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
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 |
|---|---|---|---|
| * | K130439 | External Counterpulsation Device with SP02 MornitoringSummary page 4…gqing Psk Sci-tech Development Co., Ltd. Trade/Device Name: External Counterpulsation Device with SPO2 Monitoring Model: P-ECP/TI 510(k) #: K130439 2) Reference Device Sponsor: Vamed Medical Instrument Co., Ltd. Device Name: External Counterpulsation Syste… | 2013 |
| † | K190683 | External Counterpulsation System | 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?
- Its one ancestor has no recall.
- 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. 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 OM-A 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/K191955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191955: Enhanced External Counter Pulsation Device Plus Omay-A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191955
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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