510(k) Report

510(k) · Cleared

Cleared

ProtekDuo Veno-Venous Cannula Sets

K232480510(k) TraditionalCleared Oct 6, 202351-day reviewClass II21 CFR 870.4100

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

Cardiacassist, Inc. · PZS Dual Lumen Ecmo Cannula

Cleared on Oct 6, 2023 as substantially equivalent to K140999 (Cardiacassist, Inc., 2014) and 4 other predicates after a 51-day review. Its family tree reaches back 5 generations to 2001.

Decided
Oct 6, 2023
Review
51 days
Class
Class II
Product code
PZS
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K003288 (2001). 9 ancestors in all, the oldest K924642 (1993). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2018: 1 other ancestor2017: 1 other ancestor2014: 1 other ancestor1993: 1 other ancestorK003288 · Origen Dual Lumen Catheter · Origen Biomedical, Inc. · 2001K081820 · Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR · Avalon Laboratories, LLC · 2008K140999 · Tandemheart Veno-Venous Cannula · Cardiacassist, Inc. · 2014K160257 · PROTEK Duo 31 Fr. Veno-Venous Cannula Set · Cardiacassist, Inc. · 2016 · recalledK181150 · ProtekDuo Mini Veno-Venous Cannula Set · Cardiacassist, Inc. · 201819901995200020052010201520202025
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 1 other ancestor K181150 · ProtekDuo Mini Veno-Venous Cannula Set · Cardiacassist, Inc. · 2018K160257 · PROTEK Duo 31 Fr. Veno-Venous Cannula Set · Cardiacassist, Inc. · 2016 · recalledK140999 · Tandemheart Veno-Venous Cannula · Cardiacassist, Inc. · 2014K081820 · Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR · Avalon Laboratories, LLC · 2008K003288 · Origen Dual Lumen Catheter · Origen Biomedical, Inc. · 2001−50
  1. Root · 5 generations backK003288 Origen Dual Lumen CatheterOrigen Biomedical, Inc. · 2001
  2. 4 generations backK081820 Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR…Avalon Laboratories, LLC · 2008
  3. 3 generations backK140999 Tandemheart Veno-Venous CannulaCardiacassist, Inc. · 2014
  4. 2 generations backK160257 PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc. · 2016 · Recalled
  5. 1 generation backK181150 ProtekDuo Mini Veno-Venous Cannula SetCardiacassist, Inc. · 2018
  6. This deviceK232480 ProtekDuo Veno-Venous Cannula SetsCardiacassist, Inc. · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K003288Origen Dual Lumen CatheterOrigen Biomedical, Inc.2001—
−4K081820Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR…Avalon Laboratories, LLC2008—
−3K140999Tandemheart Veno-Venous CannulaCardiacassist, Inc.2014—
−2K160257PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc.20161
−1K181150ProtekDuo Mini Veno-Venous Cannula SetCardiacassist, Inc.2018—
0 (this device)K232480ProtekDuo Veno-Venous Cannula SetsCardiacassist, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
201410
201710
201810
FIG. 1 — Lineage of K232480, 2001–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 PZS? 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 PZS device

  1. #1 K203409 MC3 Crescent Jugular Dual Lumen Catheterscore 2.2 · 4 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (6)

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
*K140999Tandemheart Veno-Venous Cannula
Summary page 4
…Code PZS) Primary Predicate Device: 81 FR 7451, Feb. 12, 2016 Secondary (Reference) Devices: ProtekDuo 29 Fr. Veno-Venous Cannula (K140999) ProtekDuo 31 Fr. Veno-Venous Cannula (K160257) ProtekDuo 31 Fr. RD Veno-…
Cardiacassist, Inc.2014—
*K160257PROTEK Duo 31 Fr. Veno-Venous Cannula Set
Summary page 4
…condary (Reference) Devices: ProtekDuo 29 Fr. Veno-Venous Cannula (K140999) ProtekDuo 31 Fr. Veno-Venous Cannula (K160257) ProtekDuo 31 Fr. RD Veno-Venous Cannula (K181150) Avalon Elite Bi-Caval…
Cardiacassist, Inc.20161
*K181150ProtekDuo Mini Veno-Venous Cannula Set
Summary page 4
…-Venous Cannula (K140999) ProtekDuo 31 Fr. Veno-Venous Cannula (K160257) ProtekDuo 31 Fr. RD Veno-Venous Cannula (K181150) Avalon Elite Bi-Caval Dual Lumen Catheter (K081820) MC3 Jugular Dual Lum…
Cardiacassist, Inc.2018—
*K081820Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR
Summary page 4
…us Cannula (K160257) ProtekDuo 31 Fr. RD Veno-Venous Cannula (K181150) Avalon Elite Bi-Caval Dual Lumen Catheter (K081820) MC3 Jugular Dual Lumen Catheter (K180151) Device Description: Each ProtekDuo Veno-Venous Cannula…
Avalon Laboratories, LLC2008—
*K180151MC3 Jugular Dual Lumen Catheter
Summary page 4
…eno-Venous Cannula (K181150) Avalon Elite Bi-Caval Dual Lumen Catheter (K081820) MC3 Jugular Dual Lumen Catheter (K180151) Device Description: Each ProtekDuo Veno-Venous Cannula Set includes a dual lumen cannula and an introducer. The introducer is…
Mc3 Incorporated2018—
*—81 FR 7451, Feb. 12, 2016
Named without a submission number
—

Also cleared against K140999: 2 other devices →

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 22 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
  • 2 of the 9 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K140999.

How does its category compare?

All PZS devices

PZS Dual Lumen Ecmo Cannula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · PZS

1in 2023

2017: 12018: 12021: 12023: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PZS

Too few PZS 510(k)s in any year since 2007 to give a median.

Recalls per year · PZS

No recall names PZS since 2007.

Adverse event reports per year · PZS

34in 2025

2019: 12020: 62021: 122022: 282023: 102024: 112025: 34
2007high 34 (2025) · low 0 (2007)2025

MAUDE reports naming product code PZS, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20171—00
20181—00
20190—01
20200—06
20211—012
20220—028
20231—010
20240—011
20250—034
20260—0—

What is it indicated for?

The ProtekDuo Veno-Venous Cannula is a single use dual lumen cannula, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

Indications for use as stated in the FDA summary.

Also cleared against K140999

2 other devices cite the same predicate.

  • K162214Protek Solo 24 Fr Venous Cannula SetCardiacassist, Inc. · 20161 recall
  • K160257PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc. · 20161 recall

More from Cardiacassist, Inc.

21 FDA decisions under this applicant name. See the company

  • K233736LifeSPARC SystemCardiacassist, Inc. · 2024
  • K232132LifeSPARC SystemCardiacassist, Inc. · 2023
  • K211830LifeSPARC SystemCardiacassist, Inc. · 2022
  • K202751TandemHeart Pump and Escort ControllerCardiacassist, Inc. · 2021
  • K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc. · 20192 Class I recalls

Recent decisions in PZS

The PZS category page

  • K203409MC3 Crescent Jugular Dual Lumen CatheterMc3, Inc. · 2021
  • K180151MC3 Jugular Dual Lumen CatheterMc3 Incorporated · 2018
  • K171610MC3 QuickFlow Dual Lumen CatheterMc3 Incorporated · 2017

https://510kreport.com/device/K232480 · printed Nov 6, 2026

Cite this page

510(k) Report. “K232480: ProtekDuo Veno-Venous Cannula Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232480

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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