510(k) · Cleared
ClearedVasogenics Eecp-MC2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vasogenics, Inc. · DRN Device, Counter-Pulsating, External
Cleared on Feb 23, 1995 after a 398-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 11 later devices descend from it.
- Decided
- Feb 23, 1995
- Review
- 398 days
- Class
- Class II
- Product code
- DRN
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 4 citing it directly.
- This deviceK940264 Vasogenics Eecp-MC2Vasogenics, Inc. · 1995
- Descendant · cites it directly · 7 of its ownK020857 Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced…Vasomedical, Inc. · 2002
- Descendant · 2 generations on · 3 of its ownK022107 Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK030587 External Counterpulsation (Ecp) Model US-EcpS-Tct Health, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK023701 Angionew-IVLiving Data Technologies Corporation · 2003
- Descendant · 2 generations on · 1 of its ownK023427 Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2003
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K020857Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation…Vasomedical, Inc. · 2002 · cites it directly7descendants
- K022107Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2002 · 2 generations on3descendants
- K030587External Counterpulsation (Ecp) Model US-EcpS-Tct Health, Inc. · 2003 · cites it directly1descendant
- K023701Angionew-IVLiving Data Technologies Corporation · 2003 · cites it directly1descendant
- K023427Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2003 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940264 | Vasogenics Eecp-MC2 | Vasogenics, Inc. | 1995 | — |
| +1 | 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 | K030587 | External Counterpulsation (Ecp) Model US-Ecp | S-Tct Health, Inc. | 2003 | — |
| +1 | K023701 | Angionew-IV | Living Data Technologies Corporation | 2003 | — |
| +2 | K023427 | Cardiassist Counterpulsation System, Model Mark 3000 | Cardiomedics, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (11)
See all 114 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, K020857 (Vasomedical, Inc., 2002) has gone furthest, with 7 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 | — |
https://510kreport.com/device/K940264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940264: Vasogenics Eecp-MC2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940264
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026