510(k) Report

FDA applicant

Maquet Cardiopulmonary, AG

Hirrlingen, DE44 decisions2005–2015285 recalls

FDA records 44 decisions for Maquet Cardiopulmonary, AG (Hirrlingen, DE) from 2005 to 2015: 44 510(k) clearances. Most are in product codes DTZ (Oxygenator, Cardiopulmonary Bypass) and DTN (Reservoir, Blood, Cardiopulmonary Bypass). Its devices cite 107 predicates, 62 of them its own earlier devices. 285 recalls are linked to its devices, 4 Class I.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Maquet Cardiopulmonary, AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007: 12008: 62009: 122010: 22011: 62013: 72014: 32015: 1
2007high 12 (2009) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

4in 2026

2010: 22011: 22012: 12013: 32014: 32015: 22016: 72017: 332018: 3, 2 Class I2019: 186, 1 Class I2020: 32022: 52023: 25, 1 Class I2024: 52025: 12026 (partial year): 4
2007high 186 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Maquet Cardiopulmonary, AG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DTZOxygenator, Cardiopulmonary Bypass13decisions
  • DTNReservoir, Blood, Cardiopulmonary Bypass7decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass7decisions
  • KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type5decisions
  • DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line3decisions
  • DTRHeat-Exchanger, Cardiopulmonary Bypass2decisions

Also: DWE (2), DTQ (2), KDI (1), DRY (1), DWC (1).

Whose devices does it build on?

Its devices cite 107 predicates; 62 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 67 times; 62 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K082117Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating, Model# Hmo 70000, Hmo 71000Maquet Cardiopulmonary, AG · 200912cite it
  • K090511Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model BEHMO70000,Beq-HMO70000Maquet Cardiopulmonary, AG · 20095cite it
  • K071774Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model BE-Hmod 2000, Beq-Hmod 2030Maquet Cardiopulmonary, AG · 20085cite it
  • K080592HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG · 20084cite it
  • K061072Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32Maquet Cardiopulmonary, AG · 20064cite it
  • K053025Jostra HLM Tubing SetMaquet Cardiopulmonary, AG · 20053cite it

What has FDA decided for it lately?

  • K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG · 20152 recalls
  • K140569Antegrade Cardioplegia Cannula (N-Type)Maquet Cardiopulmonary, AG · 2014
  • K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal…Maquet Cardiopulmonary, AG · 20142 Class I recalls
  • K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 20141 Class I recall
  • K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG · 2013
  • K132166Venous Hardshell Cardiotomy Reservoir; Non-Coated, Non-Tight/ Vacuum-Tight/ with Softline Coating…Maquet Cardiopulmonary, AG · 2013
  • K132829Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG · 20131 recall
  • K131666Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline CoatingMaquet Cardiopulmonary, AG · 20133 recalls

All 44 as Maquet Cardiopulmonary, AG →

What has been recalled?

285 recalls linked to its devices; the latest:

  • K131666Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA)…Jul 31, 2026Class II
  • K131666Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA)…Jul 31, 2026Class II
  • K131666Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA)…Jul 31, 2026Class II
  • K133598Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;Jan 9, 2026Class II
  • K102726Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the…Apr 30, 2025Class II
  • K133598CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.Apr 15, 2024Class II

Other applicant names beginning “Maquet”

FDA records each applicant name separately; these may or may not be the same firm.

Maquet Critical Care AB 20Maquet Cardiovascular, LLC 15Maquet GmbH 8Maquet Critica Care AB 1Maquet GmbH (A Getinge Group Company) 1