510(k) Report

FDA applicant

Jostra AG

Oxford, PA14 decisions2000–20048 recalls

FDA records 14 decisions for Jostra AG (Oxford, PA) from 2000 to 2004: 14 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DWC (Controller, Temperature, Cardiopulmonary Bypass). Its devices cite 2 predicates, 0 of them its own earlier devices. 8 recalls are linked to its devices.

FDA’s records also spell it “Jostra AB”.

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 Jostra AG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Jostra AG since 2007.

Recalls per year

1in 2021

2012: 12015: 12016: 12018: 32021: 1
2007high 3 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass9decisions
  • DWCController, Temperature, Cardiopulmonary Bypass1decision
  • DPTProbe, Blood-Flow, Extravascular1decision
  • KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type1decision
  • DTNReservoir, Blood, Cardiopulmonary Bypass1decision
  • DTZOxygenator, Cardiopulmonary Bypass1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 0 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.

  • K031544Heater Cooler Unit, Model Hcu 30Jostra AB · 20033cite it
  • K023132Jostra Mecc SystemJostra AG · 20023cite it
  • K030264Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030Jostra AG · 20033cite it
  • K012617Jostra Arterial Perfusion Cannulae, Model a...Jostra AG · 20011cites it
  • K003551Venous Hardshell Cardiotomy Resevoir, Model VHK 4201Jostra AG · 20011cites it
  • K020515Jostra Antegrade Cardioplegia CannulaJostra AG · 20021cites it

What has FDA decided for it lately?

  • K020983Jostra Suckers, Model JSJostra AG · 2004
  • K031544Heater Cooler Unit, Model Hcu 30Jostra AB · 20034 recalls
  • K030264Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030Jostra AG · 2003
  • K020784Jostra Single Stage Venous Return CathetersJostra AG · 2003
  • K023132Jostra Mecc SystemJostra AG · 2002
  • K022022Jostra Vent Catheters, Models LV & HKVJostra AG · 2002
  • K020515Jostra Antegrade Cardioplegia CannulaJostra AG · 2002
  • K014303Jostra Retrograde Cardioplegia CannulaeJostra AG · 2002

All 13 as Jostra AG →The one decision as Jostra AB →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K031544Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for…Jul 14, 2021Class II
  • K012774Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part…May 14, 2018Class II
  • K012774Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part…May 14, 2018Class II
  • K012774Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part…May 14, 2018Class II
  • K031544Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies…Sep 27, 2016Class II
  • K031544Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product…Nov 13, 2015Class II

Other applicant names beginning “Jostra”

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

Jostra Bentley 3Jostra Medizintechnik AG 2