510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Vortex Medical Angiovac Cardiopulmonary Bypass Circuit

K092486510(k) TraditionalCleared Aug 28, 200915-day reviewClass II21 CFR 870.4390Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vortex Medical, Inc. · DWE Tubing, Pump, Cardiopulmonary Bypass

Cleared on Aug 28, 2009 as substantially equivalent to K013578 (Terumo Cardiovascular Systems Corp., 2002) and 6 other predicates after a 15-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it. It has been recalled once.

Decided
Aug 28, 2009
Review
15 days
Class
Class II
Product code
DWE
Recalls
1
Predicates
7

Its longest line of descent runs back 3 generations to K895753 (1989). 10 ancestors in all, the oldest K771692 (1977). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2002: 2 other ancestors1988: 1 other ancestor1983: 1 other ancestor1977: 1 other ancestor1980: 1 other ancestor2014: 1 descendant clearedK895753 · Brevet Disposable Connectors · Brevet, Inc. · 1989K041697 · Terumo Circuit Connectors · Terumo Cardiovascular Systems Corporation · 2004K053025 · Jostra HLM Tubing Set · Maquet Cardiopulmonary, AG · 2005 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 2 other ancestors 1 generation forward: 1 descendant K053025 · Jostra HLM Tubing Set · Maquet Cardiopulmonary, AG · 2005 · recalledK041697 · Terumo Circuit Connectors · Terumo Cardiovascular Systems Corporation · 2004K895753 · Brevet Disposable Connectors · Brevet, Inc. · 19890
  1. Root · 3 generations backK895753 Brevet Disposable ConnectorsBrevet, Inc. · 1989
  2. 2 generations backK041697 Terumo Circuit ConnectorsTerumo Cardiovascular Systems Corporation · 2004
  3. 1 generation backK053025 Jostra HLM Tubing SetMaquet Cardiopulmonary, AG · 2005 · Recalled
  4. This deviceK092486 Vortex Medical Angiovac Cardiopulmonary Bypass CircuitVortex Medical, Inc. · 2009
  5. Descendant · cites it directly · 0 of its ownK142607 AngioVac CircuitAngiodynamics · 2014 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K142607AngioVac CircuitAngiodynamics · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K895753Brevet Disposable ConnectorsBrevet, Inc.1989—
−2K041697Terumo Circuit ConnectorsTerumo Cardiovascular Systems Corporation2004—
−1K053025Jostra HLM Tubing SetMaquet Cardiopulmonary, AG20052
0 (this device)K092486Vortex Medical Angiovac Cardiopulmonary Bypass CircuitVortex Medical, Inc.2009—
+1K142607AngioVac CircuitAngiodynamics20141

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197710
198010
198310
198810
200220
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K092486, 1989–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233702 SMARxT Tubing and Connectorsscore 7.8 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K013578Pump Tubing
Summary page 1
…monary Bypass 21 CFR §870.4290, Cardiovascular, 74 DTL (Class II) Legally marketed devices to which equivalence is claimed: Terumo Pump Tubing K013578 Gish Biomedical Tubing Connectors K833322, K030077 Terumo Circuit Connectors K041697 Cobe Cardiovascular Tubing Sets K881330, K77…
Terumo Cardiovascular Systems Corp.2002—
*K833322Tubing Connectors EC-2XXX Series
Summary page 1
…CFR §870.4290, Cardiovascular, 74 DTL (Class II) Legally marketed devices to which equivalence is claimed: Terumo Pump Tubing K013578 Gish Biomedical Tubing Connectors K833322, K030077 Terumo Circuit Connectors K041697 Cobe Cardiovascular Tubing Sets K881330, K771692 Maquet Cardiopulmonary Jostra HLM Tub…
Gish Biomedical, Inc.198322
*K030077Gish Tubing and Connectors with GBS Coating
Summary page 1
…4290, Cardiovascular, 74 DTL (Class II) Legally marketed devices to which equivalence is claimed: Terumo Pump Tubing K013578 Gish Biomedical Tubing Connectors K833322, K030077 Terumo Circuit Connectors K041697 Cobe Cardiovascular Tubing Sets K881330, K771692 Maquet Cardiopulmonary Jostra HLM Tubing Set K…
Gish Biomedical, Inc.2003—
*K041697Terumo Circuit Connectors
Summary page 1
…s II) Legally marketed devices to which equivalence is claimed: Terumo Pump Tubing K013578 Gish Biomedical Tubing Connectors K833322, K030077 Terumo Circuit Connectors K041697 Cobe Cardiovascular Tubing Sets K881330, K771692 Maquet Cardiopulmonary Jostra HLM Tubing Set K053025 Intended Use / Indications…
Terumo Cardiovascular Systems Corporation2004—
*K881330Cobe Heart/Lung Perfusion and Cardioplegia Pack
Summary page 1
…equivalence is claimed: Terumo Pump Tubing K013578 Gish Biomedical Tubing Connectors K833322, K030077 Terumo Circuit Connectors K041697 Cobe Cardiovascular Tubing Sets K881330, K771692 Maquet Cardiopulmonary Jostra HLM Tubing Set K053025 Intended Use / Indications Intended for use in procedures requirin…
Cobe Laboratories, Inc.198841
*K771692Tubing Sets
Summary page 1
…nce is claimed: Terumo Pump Tubing K013578 Gish Biomedical Tubing Connectors K833322, K030077 Terumo Circuit Connectors K041697 Cobe Cardiovascular Tubing Sets K881330, K771692 Maquet Cardiopulmonary Jostra HLM Tubing Set K053025 Intended Use / Indications Intended for use in procedures requiring extraco…
Cobe Laboratories, Inc.1977—
*K053025Jostra HLM Tubing Set
Summary page 1
…edical Tubing Connectors K833322, K030077 Terumo Circuit Connectors K041697 Cobe Cardiovascular Tubing Sets K881330, K771692 Maquet Cardiopulmonary Jostra HLM Tubing Set K053025 Intended Use / Indications Intended for use in procedures requiring extracorporeal circulatory support for periods of up to six…
Maquet Cardiopulmonary, AG20052

Also cleared against K013578: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K142607AngioVac CircuitAngiodynamics20140

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 21, 2016Class IIZ-1701-2016Environmental controlMaquet 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 20 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
  • 4 of the 10 ancestors have a recall of any class.
  • Of its descendants, K142607 (Angiodynamics, 2014) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K013578.

How does its category compare?

All DWE devices

DWE Tubing, Pump, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · DWE

1in 2024

2008: 12009: 12014: 12015: 12024: 1
2007high 1 (2008) · low 0 (2007)2026

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

2007: 22009: 12010: 22011: 22014: 12017: 2
2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DWE

80in 2025

2007: 102008: 122009: 172010: 202011: 92012: 72013: 212014: 1292015: 1332016: 1512017: 1312018: 1342019: 822020: 452021: 412022: 1232023: 2862024: 2212025: 80
2007high 286 (2023) · low 7 (2012)2025

MAUDE reports naming product code DWE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—210
20081—012
20091—117
20100—220
20110—29
20120—07
20130—021
20141—1129
20151—0133
20160—0151
20170—2131
20180—0134
20190—082
20200—045
20210—041
20220—0123
20230—0286
20241—0221
20250—080
20260—0—

What is it indicated for?

Indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.

Indications for use as stated in the FDA summary.

Also cleared against K013578

2 other devices cite the same predicate.

  • K073631Orqis Extracorporeal Blood Pumping System, Model BPS-100Orqis Medical Corporation · 2008
  • K053025Jostra HLM Tubing SetMaquet Cardiopulmonary, AG · 20052 recalls

More from Vortex Medical, Inc.

3 FDA decisions under this applicant name. See the company

  • K133445Angiovac CannulaVortex Medical, Inc. · 2014
  • K091304Vortex CannulaVortex Medical, Inc. · 2009

Recent decisions in DWE

The DWE category page

  • K233702SMARxT Tubing and ConnectorsLivaNova USA, Inc. · 2024
  • K150542Terumo Pump TubingTerumo Cardiovascular Systems Corporation · 2015
  • K142607AngioVac CircuitAngiodynamics · 20141 recall
  • K080592HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG · 2008221 recalls
  • K053025Jostra HLM Tubing SetMaquet Cardiopulmonary, AG · 20052 recalls

https://510kreport.com/device/K092486 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092486: Vortex Medical Angiovac Cardiopulmonary Bypass Circuit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092486

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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