# Maquet Cardiopulmonary, AG

- Location (FDA's records): Hirrlingen, DE
- FDA decisions: 44 (2005–2015): 44 510(k) clearances
- Product codes: DTZ (13), DTN (7), DWF (7), KFM (5), DTM (3), DTR (2), DWE (2), DTQ (2), KDI (1), DRY (1), DWC (1)
- Predicates its devices cite: 107 (62 its own); citations of its devices by later devices: 67 (62 its own)
- Recalls linked to its devices: 285 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Jostra AG: 8 (https://510kreport.com/company/jostra)
- Sorin Group Italia S.R.L.: 4 (https://510kreport.com/company/sorin-group-italia)
- Jostra Medizintechnik AG: 4 (https://510kreport.com/company/jostra-medizintechnik)
- Terumo Cardiovascular Systems Corp.: 3 (https://510kreport.com/company/terumo-cardiovascular-systems)
- Minntech Corp.: 2 (https://510kreport.com/company/minntech)
- Terumo Corp.: 2 (https://510kreport.com/company/terumo)
- Medtronic Bio-Medicus, Inc.: 2 (https://510kreport.com/company/medtronic-bio-medicus)
- Jostra Bentley: 2 (https://510kreport.com/company/jostra-bentley)

## Firms that cite its devices most
- Novalung GmbH: 1 (https://510kreport.com/company/novalung)
- Qura S.R.L: 1 (https://510kreport.com/company/qura)
- Abiomed, Inc.: 1 (https://510kreport.com/company/abiomed)
- Vortex Medical, Inc.: 1 (https://510kreport.com/company/vortex-medical)
- Mapquet Cardiopulmonary AG: 1 (https://510kreport.com/company/mapquet-cardiopulmonary)

## Its most-cited devices
- K082117: Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating, Model# Hmo 70000, Hmo 71000 (2009), cited by 12
- K090511: Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model BEHMO70000,Beq-HMO70000 (2009), cited by 5
- K071774: Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model BE-Hmod 2000, Beq-Hmod 2030 (2008), cited by 5
- K080592: HLM Tubing Set with Bioline Coating (2008), cited by 4
- K061072: Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32 (2006), cited by 4
- K053025: Jostra HLM Tubing Set (2005), cited by 3

## Recent decisions
- K150267: QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators (May 7, 2015)
- K140569: Antegrade Cardioplegia Cannula (N-Type) (Nov 19, 2014)
- K141432: Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal Venous Hardhsh (Jul 7, 2014)
- K133598: Cardiohelp System (May 21, 2014)
- K133265: Quadrox-IR Adult and Small Adult (Nov 12, 2013)
- K132166: Venous Hardshell Cardiotomy Reservoir; Non-Coated, Non-Tight/ Vacuum-Tight/ with Softline Coating, Vacuum-Tight (Oct 30, 2013)
- K132829: Quadrox-I, Quadrox-ID, Quadrox-IR Oxygenators (Oct 8, 2013)
- K131666: Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline Coating (Jul 5, 2013)

Source page: https://510kreport.com/company/maquet-cardiopulmonary