Data / Medical devices / Germany / Gambro Dialysatoren GMBH

Gambro Dialysatoren GMBH: FDA-registered device maker in HECHINGEN Baden-Wurttemberg, Germany, 8 510(k) clearances

Name: Gambro Dialysatoren GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Gambro Dialysatoren GMBH is registered with the FDA (registration 9611369) in HECHINGEN Baden-Wurttemberg, Germany. It lists 7 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 24, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9611369
FEI number: 3002807035
Address: Holger - Crafoord - Strasse 26, HECHINGEN Baden-Wurttemberg, Germany, 72379
Owner or operator: Vantive US Healthcare LLC (9038727)
Roles: Manufacturer
First device listed: March 21, 2007
Registered through: 2026
Brand names listed: AK 98 Dialysis Machine, C-705 Accessory Expansion Chamber, MARS Monitor ITC US, MARS Treatment Kit Type 1116/1 - X-MARS US, Prismaflex Control Unit, POLYFLUX 140H, 170H, 210H, POLYFLUX 14L, 17L, 21L, POLYFLUX HEMODIALYZER MODEL 6H, Revaclear, Revaclear 300 and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Hemoperfusion, Sorbent	FLD	2	Manufacturer	accessdata.fda.gov
Dialyzer, Capillary, Hollow Fiber	FJI	2	Manufacturer	accessdata.fda.gov
Dialyzer, High Permeability With Or Without Sealed Dialysate System	KDI	2	Manufacturer	accessdata.fda.gov
Hemodialyzer With Expanded Solute Removal Profile	QAX	2	Manufacturer	accessdata.fda.gov
Hemodialyzer, Re-Use, High Flux	MSF	2	Manufacturer	accessdata.fda.gov
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	FJK	2	Manufacturer	accessdata.fda.gov
Subsystem, Water Purification	FIP	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 24, 2022	K213639	Revaclear 500, Revaclear 400, Revaclear 300	KDI	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
October 19, 2021	K211035	U9000 Plus Ultrafilter	FIP	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
March 10, 2021	K201809	AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory	KDI	Substantially Equivalent	Baxter Healthcare Corportation	accessdata.fda.gov
August 28, 2020	DEN190042	Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer	QAX	Unknown	Baxter Healthcare Corporation	accessdata.fda.gov
March 26, 2014	K133807	MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT	FLD	Substantially Equivalent	Gambro Renal Products, Inc.	accessdata.fda.gov
May 2, 2013	K130039	REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER	KDI	Substantially Equivalent	Gambro Renal Products, Inc.	accessdata.fda.gov
December 9, 2005	K051520	GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H	KDI	Substantially Equivalent	Gambro Renal Products	accessdata.fda.gov
May 27, 2005	K043342	POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR	FJI	Substantially Equivalent	Gambro Renal Products	accessdata.fda.gov

Compare with other makers

Updated January 24, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.