# Jostra AG

- Location (FDA's records): Oxford, PA
- FDA decisions: 14 (2000–2004): 14 510(k) clearances
- Names in FDA's records: Jostra AG (13); Jostra AB (1)
- Product codes: DWF (9), DWC (1), DPT (1), KFM (1), DTN (1), DTZ (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 12 (0 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- 3M Health Care, Sarns: 1 (https://510kreport.com/company/3m-health-care-sarns)
- Jostra Bentley: 1 (https://510kreport.com/company/jostra-bentley)

## Firms that cite its devices most
- Maquet Cardiopulmonary, AG: 8 (https://510kreport.com/company/maquet-cardiopulmonary)
- Lifebridge Medizintechnik AG: 1 (https://510kreport.com/company/lifebridge-medizintechnik)
- Polystan A/S: 1 (https://510kreport.com/company/polystan-a-s)
- Cincinnati Sub-Zero Products, Inc.: 1 (https://510kreport.com/company/cincinnati-sub-zero-products)
- Sorin Group Deutschland GmbH: 1 (https://510kreport.com/company/sorin-group-deutschland)

## Its most-cited devices
- K031544: Heater Cooler Unit, Model Hcu 30 (2003), cited by 3
- K023132: Jostra Mecc System (2002), cited by 3
- K030264: Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030 (2003), cited by 3
- K012617: Jostra Arterial Perfusion Cannulae, Model a... (2001), cited by 1
- K003551: Venous Hardshell Cardiotomy Resevoir, Model VHK 4201 (2001), cited by 1
- K020515: Jostra Antegrade Cardioplegia Cannula (2002), cited by 1

## Recent decisions
- K020983: Jostra Suckers, Model JS (Jan 30, 2004)
- K031544: Heater Cooler Unit, Model Hcu 30 (Aug 7, 2003)
- K030264: Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030 (Feb 26, 2003)
- K020784: Jostra Single Stage Venous Return Catheters (Jan 9, 2003)
- K023132: Jostra Mecc System (Dec 17, 2002)
- K022022: Jostra Vent Catheters, Models LV & HKV (Sep 11, 2002)
- K020515: Jostra Antegrade Cardioplegia Cannula (Apr 24, 2002)
- K014303: Jostra Retrograde Cardioplegia Cannulae (Mar 26, 2002)

Source page: https://510kreport.com/company/jostra