510(k) · Cleared
Recalled · 2009Cardiassist Counter Pulsation System Series 4000/5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiomedics, Inc. · DRN Device, Counter-Pulsating, External
Cleared on Mar 31, 2005 as substantially equivalent to K023427 (Cardiomedics, Inc., 2003) and 1 other predicate after a 64-day review. Its family tree reaches back 4 generations to 1995. It has been recalled once.
- Decided
- Mar 31, 2005
- Review
- 64 days
- Class
- Class II
- Product code
- DRN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K940264 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK940264 Vasogenics Eecp-MC2Vasogenics, Inc. · 1995
- 3 generations backK020857 Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced…Vasomedical, Inc. · 2002
- 2 generations backK022107 Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2002
- 1 generation backK023427 Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2003
- This deviceK050172 Cardiassist Counter Pulsation System Series 4000/5000Cardiomedics, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940264 | Vasogenics Eecp-MC2 | Vasogenics, Inc. | 1995 | — |
| −3 | K020857 | Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External… | Vasomedical, Inc. | 2002 | — |
| −2 | K022107 | Cardiassist Counterpulsation System, Model Mark 3000 | Cardiomedics, Inc. | 2002 | — |
| −1 | K023427 | Cardiassist Counterpulsation System, Model Mark 3000 | Cardiomedics, Inc. | 2003 | — |
| 0 (this device) | K050172 | Cardiassist Counter Pulsation System Series 4000/5000 | Cardiomedics, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K023427 | Cardiassist Counterpulsation System, Model Mark 3000Summary page 1…ECP System, Mark 3000 cleared for market entry under 510(k) K023427 on January 7, 2003 as well as technologically and functionally… | 2003 |
| * | K023016 | Nicore Model NCP-1 External Counterpulsation DeviceSummary page 1…functionally equivalent to the Nicore NCP-1 Device, cleared for market entry under 510(k) K023016 on December 4, 2002. (ardiomedics, Inc. considers ihis application to be,onfidential and not snbject to disclosur… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 9, 2009 | Not classified | Z-1582-2009 | Software design | Cuff may underinflate, or device may stop working during use. Cardioassist software version 4.3.1 utilized a signal from the plethysmograph that was found not to be sensitive enough due to the shape of the waveform in certain… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.2 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.
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 Cardiomedics, Inc., CardiAssist Counter Pulsation System - Series 4000 is intended to provide external counterpulsation (ECP) for the treatment of ischemic heart disease by increasing perfusion during diastole in people with chronic angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure or myocardial infarction and may enhance coronary function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050172: Cardiassist Counter Pulsation System Series 4000/5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050172
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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