510(k) · Cleared
Recalled · Class II · 2016AngioVac Circuit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Angiodynamics · DWE Tubing, Pump, Cardiopulmonary Bypass
Cleared on Dec 11, 2014 as substantially equivalent to K092486 (Vortex Medical, Inc., 2009) after an 87-day review. Its family tree reaches back 4 generations to 1989. It has been recalled once.
- Decided
- Dec 11, 2014
- Review
- 87 days
- Class
- Class II
- Product code
- DWE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K895753 (1989). 11 ancestors in all, the oldest K771692 (1977). No later device cites it as a predicate yet.
- Root · 4 generations backK895753 Brevet Disposable ConnectorsBrevet, Inc. · 1989
- 3 generations backK041697 Terumo Circuit ConnectorsTerumo Cardiovascular Systems Corporation · 2004
- 2 generations backK053025 Jostra HLM Tubing SetMaquet Cardiopulmonary, AG · 2005 · Recalled
- 1 generation backK092486 Vortex Medical Angiovac Cardiopulmonary Bypass CircuitVortex Medical, Inc. · 2009 · Recalled
- This deviceK142607 AngioVac CircuitAngiodynamics · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K895753 | Brevet Disposable Connectors | Brevet, Inc. | 1989 | — |
| −3 | K041697 | Terumo Circuit Connectors | Terumo Cardiovascular Systems Corporation | 2004 | — |
| −2 | K053025 | Jostra HLM Tubing Set | Maquet Cardiopulmonary, AG | 2005 | 2 |
| −1 | K092486 | Vortex Medical Angiovac Cardiopulmonary Bypass Circuit | Vortex Medical, Inc. | 2009 | 1 |
| 0 (this device) | K142607 | AngioVac Circuit | Angiodynamics | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 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 DWE? 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 DWE device
- #1 K233702 SMARxT Tubing and Connectorsscore 7.8 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K092486 | Vortex Medical Angiovac Cardiopulmonary Bypass CircuitSummary page 4…cation: Class II C. Predicate Device(s) Trade Name 510(k) Company Vortex Medical, Inc. AngioVac K092486 Vortex Medical Inc. Cardiopulmonary Bypass Circuit (acquired by AngioDynamics Inc.) D. Dev… | 2009 |
| † | K133445 | Angiovac Cannula | 2014 |
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 |
|---|---|---|---|---|
| Mar 21, 2016 | Class II | Z-1702-2016 | Environmental control | Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 5.3 years on median.
- 5 of the 11 ancestors have a recall of any class.
How does its category compare?
All DWE devicesDWE Tubing, Pump, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DWE
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DWE
Too few DWE 510(k)s in any year since 2007 to give a median.
Recalls per year · DWE
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWE
80in 2025
MAUDE reports naming product code DWE, 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 | — | 2 | 10 |
| 2008 | 1 | — | 0 | 12 |
| 2009 | 1 | — | 1 | 17 |
| 2010 | 0 | — | 2 | 20 |
| 2011 | 0 | — | 2 | 9 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 21 |
| 2014 | 1 | — | 1 | 129 |
| 2015 | 1 | — | 0 | 133 |
| 2016 | 0 | — | 0 | 151 |
| 2017 | 0 | — | 2 | 131 |
| 2018 | 0 | — | 0 | 134 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 45 |
| 2021 | 0 | — | 0 | 41 |
| 2022 | 0 | — | 0 | 123 |
| 2023 | 0 | — | 0 | 286 |
| 2024 | 1 | — | 0 | 221 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.
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/K142607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142607: AngioVac Circuit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142607
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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