QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS— 510(k) K132829

Clearance details

Applicant

Maquet Cardiopulmonary, AG

Product code

Code DTZ

Device class

Class 2

Regulation

21 CFR 870.4350

Advisory panel

Cardiovascular

Date received

2013-09-09

Decision date

2013-10-08

Decision

Substantially Equivalent

Clearance type

Special

Location

Wayne, NJ, US

• K253838 — Lifemotion Disposable Membrane Oxygenator2026-03-16
• K240934 — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3) +2 more2026-03-12
• K250821 — Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300) +2 more2025-12-12
• K242503 — Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)2025-11-24
• K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E22024-09-12

• K150267 — QUADROX-i Adult/Small Adult Oxygenators; QUADROX-iD Adult Oxygenators2015-05-07
• K140569 — ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)2014-11-19
• K141432 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH2014-07-07
• K133598 — CARDIOHELP SYSTEM2014-05-21
• K133265 — QUADROX-IR ADULT AND SMALL ADULT2013-11-12

Death

182

Injury

422

Malfunction

3,636

Total

4,240

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1689-2015 — Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The oxygenator with diffusion membrane cannot be used for the administration of volatile anesthetic gases because the gas molecules are unable to pass through the diffusion membrane. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.Class II·Terminated·Maquet Cardiovascular Us Sales, Llc·20150305

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132829.