510(k) · Cleared
ClearedAcs Model NCP-2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Cardiac Systems · DRN Device, Counter-Pulsating, External
Cleared on Dec 9, 2004 as substantially equivalent to K980937 (Nicore Equipment & Leasing, Inc., 2000) and 1 other predicate after a 93-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Dec 9, 2004
- Review
- 93 days
- Class
- Class II
- Product code
- DRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K980937 (2000). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK980937 Nicore Model Esp -1Nicore Equipment & Leasing, Inc. · 2000
- This deviceK042413 Acs Model NCP-2Applied Cardiac Systems · 2004
- Descendant · cites it directly · 3 of its ownK152115 Renew NCP-5 External Counterpulsation SystemStage 2 Innovations · 2015
- Descendant · 2 generations on · 2 of its ownK173483 Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLC · 2018
- Descendant · 3 generations on · 1 of its ownK190683 External Counterpulsation SystemVamed Medical Instrument Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK250756 Pression Wave PRO External Counter-Pulsation SystemPression, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK202108 External Counterpulsation System, SoulaireVamed Medical Instrument Co., Ltd. · 2020
Most influential descendants
Showing 5 of 5 · See all- K152115Renew NCP-5 External Counterpulsation SystemStage 2 Innovations · 2015 · cites it directly3descendants
- K173483Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLC · 2018 · 2 generations on2descendants
- K190683External Counterpulsation SystemVamed Medical Instrument Co., Ltd. · 2019 · 3 generations on1descendant
- K250756Pression Wave PRO External Counter-Pulsation SystemPression, Inc. · 2025 · cites it directly0descendants
- K202108External Counterpulsation System, SoulaireVamed Medical Instrument Co., Ltd. · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980937 | Nicore Model Esp -1 | Nicore Equipment & Leasing, Inc. | 2000 | — |
| 0 (this device) | K042413 | Acs Model NCP-2 | Applied Cardiac Systems | 2004 | — |
| +1 | K152115 | Renew NCP-5 External Counterpulsation System | Stage 2 Innovations | 2015 | — |
| +2 | K173483 | Pure Flow External Counter-Pulsation Device | Xtreem Pulse, LLC | 2018 | — |
| +3 | K190683 | External Counterpulsation System | Vamed Medical Instrument Co., Ltd. | 2019 | — |
| +1 | K250756 | Pression Wave PRO External Counter-Pulsation System | Pression, Inc. | 2025 | — |
| +4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K980937 | Nicore Model Esp -1Summary page 1…ssification Name: Device, Counter-pulsating, External 5. Predicate Device: Nicore NCP (ESP) External Counterpulsation Device K980937 and by reference K023016 (adding Congestive heart failure to the indications for use of the device)… | 2000 |
| * | K023016 | Nicore Model NCP-1 External Counterpulsation DeviceSummary page 1…Device, Counter-pulsating, External 5. Predicate Device: Nicore NCP (ESP) External Counterpulsation Device K980937 and by reference K023016 (adding Congestive heart failure to the indications for use of the device) 6. Device Description:… | 2002 |
What descends from it? (5)
2 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K152115 (Stage 2 Innovations, 2015) has gone furthest, with 3 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?
Current indications for use of the ACSTM Model NCP-2 are:
Stable Angina Pectoris
Unstable Angina Pectoris
Acute Myocardial Infarction
Cardiogenic Shock
Congestive Heart Failure
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042413 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042413: Acs Model NCP-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042413
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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