510(k) Report

FDA product code · Cardiovascular

Dual Lumen Ecmo Cannula

PZSClass II21 CFR 870.4100510(k) required4 decisions since 20170 recalls

4 FDA decisions since 2017. 510(k) reviews decided 2021–2025 took a median of 108 days (half between 80 and 137). No recall names this code. The most-cited predicate is K180151, named by 2 later devices.

Long term support greater than 6 hours for acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

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

FIG. A — Illustration, cardiovascular panel

Twenty years of PZS at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — PZS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PZS? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PZS devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K180151MC3 Jugular Dual Lumen CatheterMc3 Incorporated · 20182cite it
  • K171610MC3 QuickFlow Dual Lumen CatheterMc3 Incorporated · 20171cites it

Which PZS devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K232480ProtekDuo Veno-Venous Cannula SetsCardiacassist, Inc. · 20235generations
  • K203409MC3 Crescent Jugular Dual Lumen CatheterMc3, Inc. · 20214generations
  • K180151MC3 Jugular Dual Lumen CatheterMc3 Incorporated · 20183generations
  • K171610MC3 QuickFlow Dual Lumen CatheterMc3 Incorporated · 20172generations

What has FDA decided in PZS lately?

  • K232480ProtekDuo Veno-Venous Cannula SetsCardiacassist, Inc. · 2023
  • K203409MC3 Crescent Jugular Dual Lumen CatheterMc3, Inc. · 2021
  • K180151MC3 Jugular Dual Lumen CatheterMc3 Incorporated · 2018
  • K171610MC3 QuickFlow Dual Lumen CatheterMc3 Incorporated · 2017

All 4 PZS decisions →

Related product codes

Other codes under 21 CFR 870.4100.

QWF Tubing, Long Term Support Greater Than 6 HoursQNR Blood Pump For Ecmo, Long-Term (> 6 Hours) UseBYS Oxygenator, Long Term Support Greater Than 6…QHW Single Lumen Ecmo CannulaQJZ Extracorporeal System For Long-Term…