510(k) · Cleared
ClearedNicore Model NCP-1 External Counterpulsation Device
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 Dec 4, 2002 after an 85-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Dec 4, 2002
- Review
- 85 days
- Class
- Class II
- Product code
- DRN
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK023016 Nicore Model NCP-1 External Counterpulsation DeviceNicore Equipment & Leasing, Inc. · 2002
- 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 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · 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) | K023016 | Nicore Model NCP-1 External Counterpulsation Device | Nicore Equipment & Leasing, Inc. | 2002 | — |
| +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 |
| 2005 | 1 | 0 |
| 2008 | 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 10.8 · 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? (8)
3 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, 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?
The NICORE Model NCP-I is used 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 summary.
https://510kreport.com/device/K023016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023016: Nicore Model NCP-1 External Counterpulsation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023016
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