510(k) · Cleared
ClearedNicore Model Esp -1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nicore Equipment & Leasing, Inc. · DRN Device, Counter-Pulsating, External
Cleared on Sep 15, 2000 after a 918-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Sep 15, 2000
- Review
- 918 days
- Class
- Class II
- Product code
- DRN
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK980937 Nicore Model Esp -1Nicore Equipment & Leasing, Inc. · 2000
- Descendant · cites it directly · 5 of its ownK042413 Acs Model NCP-2Applied Cardiac Systems · 2004
- Descendant · 2 generations on · 3 of its ownK152115 Renew NCP-5 External Counterpulsation SystemStage 2 Innovations · 2015
- Descendant · 3 generations on · 2 of its ownK173483 Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLC · 2018
- Descendant · 4 generations on · 1 of its ownK190683 External Counterpulsation SystemVamed Medical Instrument Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK250756 Pression Wave PRO External Counter-Pulsation SystemPression, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K042413Acs Model NCP-2Applied Cardiac Systems · 2004 · cites it directly5descendants
- K152115Renew NCP-5 External Counterpulsation SystemStage 2 Innovations · 2015 · 2 generations on3descendants
- K173483Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLC · 2018 · 3 generations on2descendants
- K190683External Counterpulsation SystemVamed Medical Instrument Co., Ltd. · 2019 · 4 generations on1descendant
- K250756Pression Wave PRO External Counter-Pulsation SystemPression, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980937 | Nicore Model Esp -1 | Nicore Equipment & Leasing, Inc. | 2000 | — |
| +1 | K042413 | Acs Model NCP-2 | Applied Cardiac Systems | 2004 | — |
| +2 | K152115 | Renew NCP-5 External Counterpulsation System | Stage 2 Innovations | 2015 | — |
| +3 | K173483 | Pure Flow External Counter-Pulsation Device | Xtreem Pulse, LLC | 2018 | — |
| +4 | K190683 | External Counterpulsation System | Vamed Medical Instrument Co., Ltd. | 2019 | — |
| +2 | K250756 | Pression Wave PRO External Counter-Pulsation System | Pression, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | — | Vasomedical Model EECP-MC2 Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042413 | Acs Model NCP-2 | 2004 | 5 |
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, K042413 (Applied Cardiac Systems, 2004) has gone furthest, with 5 descendants 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.
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?
Stable Angine Pectoris
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/K980937 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980937: Nicore Model Esp -1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980937
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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