510(k) · Cleared
ClearedEecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation Eecp MC-2 External Counter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vasomedical, Inc. · DRN Device, Counter-Pulsating, External
Cleared on Jun 14, 2002 as substantially equivalent to K003469 (Vasomedical, Inc., 2000) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1995. 7 later devices descend from it.
- Decided
- Jun 14, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- DRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K940264 (1995). 2 ancestors in all. 7 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK940264 Vasogenics Eecp-MC2Vasogenics, Inc. · 1995
- This deviceK020857 Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced…Vasomedical, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK022107 Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK023701 Angionew-IVLiving Data Technologies Corporation · 2003
- Descendant · cites it directly · 1 of its ownK023427 Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK082134 Circulator BootCirculator Boot Corp. · 2009
- Descendant · 2 generations on · 0 of its ownK050172 Cardiassist Counter Pulsation System Series 4000/5000Cardiomedics, Inc. · 2005 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K022107Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2002 · cites it directly3descendants
- K023701Angionew-IVLiving Data Technologies Corporation · 2003 · cites it directly1descendant
- K023427Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2003 · cites it directly1descendant
- K082134Circulator BootCirculator Boot Corp. · 2009 · cites it directly0descendants
- K050172Cardiassist Counter Pulsation System Series 4000/5000Cardiomedics, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940264 | Vasogenics Eecp-MC2 | Vasogenics, Inc. | 1995 | — |
| 0 (this device) | 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 | — |
| +1 | K023701 | Angionew-IV | Living Data Technologies Corporation | 2003 | — |
| +1 | K023427 | Cardiassist Counterpulsation System, Model Mark 3000 | Cardiomedics, Inc. | 2003 | — |
| +1 | K082134 | Circulator Boot | Circulator Boot Corp. | 2009 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003469 | Eecp Therapy System, Model TS3Summary page 1…EECP@Therapy System Model TS3 with Pulse Oximetry is substantially equivalent to the EECP@Therapy System Model TS3 (K003469) and, by reference, to the EECP@MC-2 (K940264). 6. Device Description: The EECP" Therapy System… | 2000 |
| * | K940264 | Vasogenics Eecp-MC2Summary page 1…try is substantially equivalent to the EECP@Therapy System Model TS3 (K003469) and, by reference, to the EECP@MC-2 (K940264). 6. Device Description: The EECP" Therapy System Model TS3 with Pulse Oximetry is comprised of… | 1995 |
| † | K982969 | Nonin Pulse Oximeter and Carbon Dioxide Detector, Models 9843, 9845 and 9847 | 1999 |
| † | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | 1998 |
| † | K970763 | Modular Telemetry System (MTS) Option for the Mde Escort II Monitor | 1997 |
| † | K002690 | Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500 | 2000 |
What descends from it? (7)
5 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, K022107 (Cardiomedics, Inc., 2002) 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?
Vasomedical, Inc.’s EECP® Therapy System Model TS3 with Pulse Oximetry is a non-invasive external counterpulsation device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction, or cardiogenic shock. Vasomedical, Inc.’s EECP® Therapy System Model TS3 is a non-invasive external counterpulsation device intended for use in the treatment of patients with congestive heart…
Read the full statement (111 words)
Vasomedical, Inc.’s EECP® Therapy System Model TS3 with Pulse Oximetry is a non-invasive external counterpulsation device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction, or cardiogenic shock.
Vasomedical, Inc.’s EECP® Therapy System Model TS3 is a non-invasive external counterpulsation device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction, or cardiogenic shock.
Vasomedical, Inc.’s Enhanced External Counterpulsation EECP® MC-2 is a non-invasive external counterpulsation device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction, or cardiogenic shock.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020857: Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation Eecp MC-2 External Counter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020857
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