510(k) · Cleared
ClearedCardiassist Counterpulsation System, Model Mark 3000
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 Jan 7, 2003 as substantially equivalent to K022107 (Cardiomedics, Inc., 2002) and 1 other predicate after an 88-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Jan 7, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- DRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K940264 (1995). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK940264 Vasogenics Eecp-MC2Vasogenics, Inc. · 1995
- 2 generations backK020857 Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced…Vasomedical, Inc. · 2002
- 1 generation backK022107 Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2002
- This deviceK023427 Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK050172 Cardiassist Counter Pulsation System Series 4000/5000Cardiomedics, Inc. · 2005 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K050172Cardiassist Counter Pulsation System Series 4000/5000Cardiomedics, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940264 | Vasogenics Eecp-MC2 | Vasogenics, Inc. | 1995 | — |
| −2 | K020857 | Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External… | Vasomedical, Inc. | 2002 | — |
| −1 | K022107 | Cardiassist Counterpulsation System, Model Mark 3000 | Cardiomedics, Inc. | 2002 | — |
| 0 (this device) | K023427 | Cardiassist Counterpulsation System, Model Mark 3000 | Cardiomedics, Inc. | 2003 | — |
| +1 | K050172 | Cardiassist Counter Pulsation System Series 4000/5000 | Cardiomedics, Inc. | 2005 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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? (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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050172 | Cardiassist Counter Pulsation System Series 4000/5000 | 2005 | 0 |
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K050172 (Cardiomedics, Inc., 2005) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K022107.
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., CardiAssistTM CounterPulsation System is intended to provide external
counterpulsation (ECP) by increasing perfusion during diastole for the treatment of 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, myocardial infarction and cardiogenic shock and may enhance coronary function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023427: Cardiassist Counterpulsation System, Model Mark 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023427
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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