Data / Medical devices / United States / Fresenius USA Manufacturing, Inc.

Fresenius USA Manufacturing, Inc.: FDA-registered device maker in Oregon, OH, United States, 5 510(k) clearances

Name: Fresenius USA Manufacturing, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Fresenius USA Manufacturing, Inc. is registered with the FDA (registration 3005162618) in Oregon, OH, United States. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 29, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005162618
FEI number: 1527681
Address: 750 North Lallendorf Rd, Oregon, OH, United States, 43616
Owner or operator: Fresenius Medical Care Renal Therapies Group, LLC (9030510)
Roles: Manufacturer
First device listed: March 2, 2020
Registered through: 2026
Brand names listed: 5008X CAREsystem, Citrasate Dry Acid Concentrate, Citrasate Liquid Acid Concentrate, Granuflo Dry Acid Concentrate, NaturaLyte Dry Bicarbonate (08-4112-2), NaturaLyte Dry Bicarbonate Concentrate, NaturaLyte Liquid Acid Concentrate

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Blood Circuit, Hemodialysis	KOC	2	Manufacturer	accessdata.fda.gov
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	KPO	2	Manufacturer	accessdata.fda.gov
Dialyzer, High Permeability With Or Without Sealed Dialysate System	KDI	2	Manufacturer	accessdata.fda.gov
Disinfectant, Dialysate Delivery System	NII	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 29, 2026	K253462	NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)	KPO	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC	accessdata.fda.gov
May 30, 2025	K243505	5008X Hemodialysis System	KDI	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC	accessdata.fda.gov
May 12, 2022	K212620	Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate	KPO	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC	accessdata.fda.gov
May 8, 2020	K192209	Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate	KPO	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC	accessdata.fda.gov
February 24, 2020	K191474	NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)	KPO	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC	accessdata.fda.gov

Compare with other makers

Updated January 29, 2026. 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.