510(k) · Cleared
ClearedEecp Therapy System Model TS4 with/Without Pluse Oximetry
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 Mar 1, 2004 as substantially equivalent to K020857 (Vasomedical, Inc., 2002) after a 104-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Mar 1, 2004
- Review
- 104 days
- Class
- Class II
- Product code
- DRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940264 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940264 | Vasogenics Eecp-MC2 | Vasogenics, Inc. | 1995 | — |
| −1 | K020857 | Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External… | Vasomedical, Inc. | 2002 | — |
| 0 (this device) | K033617 | Eecp Therapy System Model TS4 with/Without Pluse Oximetry | Vasomedical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (1)
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 |
|---|---|---|---|
| * | K020857 | Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation…Summary page 2…ernal Counterpuls-ation Model MC-2. FDA granted 510(k) clearance for the predicate device on June 14, 2002 (K020857, corrected letter issued June 18, 2002). 6. Device Description: Vasomedical's EECP Therap… | 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)
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 9 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- None of the 3 ancestors has a recall.
- 4 other devices also cite its predicate K020857.
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 Enhanced External Counterpulsation (EECP®) Therapy Systems are non-invasive external counterpulsation devices intended for use in the treatment of patients with stable or unstable angina, congestive heart failure, acute myocardial infarction, or cardiogenic shock
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033617: Eecp Therapy System Model TS4 with/Without Pluse Oximetry.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033617
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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