Fresenius USA Manufacturing, Inc.

FDA Device Registration & Listing · OREGON, OH, US · Registration 3005162618

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005162618
FEI Number
1527681
Entity Name
Fresenius USA Manufacturing, Inc.
City/State/Country
OREGON, OH, US
Establishment Address
750 North Lallendorf Rd, OREGON, OH 43616, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Fresenius Medical Care Renal Therapies Group, LLC (Owner Number: 9030510)
Owner / Operator Contact Address
920 WINTER STREET, --, Waltham, MA 02451, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K192209
PMA Number
N/A

All Registered Proprietary Names

NaturaLyte Dry Bicarbonate Concentrate NaturaLyte Dry Bicarbonate (08-4112-2) NaturaLyte Liquid Acid Concentrate Citrasate Liquid Acid Concentrate 5008X CAREsystem Granuflo Dry Acid Concentrate Citrasate Dry Acid Concentrate

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2020-03-02
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2026-02-03
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2022-11-21
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2025-06-03
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2025-06-03
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2025-06-03
NII Disinfectant, Dialysate Delivery System Gastroenterology, Urology Class 2 876.5860 2025-06-03
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2025-06-03
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2020-05-14

Official Correspondent

Rachel Lloyd

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fresenius Medical Care Renal Therapies Group, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3023981687 Erika of Texas Pharr, TX, US
3012364195 Fresenius Medical Care de Mexico Zapopan Jalisco, MX
3031565407 Erika de Reynosa, S.A. de C.V. CD, Reynosa Tamaulipas, MX
3005578748 Haemotec, a division of Fresenius Medical Care Canada Inc. VAUDREUIL-DORION Quebec, CA
3013546115 Fresenius USA Manufacturing, Inc. Knoxville, TN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K110578 Mar Cor Purification, Inc. MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM 2011-05-20
K811830 Cordis Corp. C-DAK DUO-FLUX ARTIFICIAL KIDNEY 1981-09-21
K070320 Edwards Lifesciences Services GmbH EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 2007-06-07
K150880 Outset Medical Tablo Console with Wireless Capability 2015-05-01

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-05 Ameriwater Inc 2
AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.
Z-0019-2025 Outset Medical, Inc. 2
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis SYS, with CDX
Z-0029-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis System without CDX
Z-0030-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis System w/Bibag

Similar Registrations

Registration Number Establishment Name Location
2431908 EDLAW PHARMACEUTICALS, INC. E Farmingdale, NY, US
9616277 S.M.A.D. L'ARBRESLE Rhone, FR
3027241826 RENAL CARE DIALYSIS SOLUTIONS, S.A. DE C.V. El Marques Queretaro, MX
1225714 Fresenius Medical Care Renal Therapies Group, LLC Waltham, MA, US
1528807 Nipro Renal Solutions USA, Corporation LEWISBERRY, PA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005162618. Last updated year: 2026. Please use registration number 3005162618 when referencing this establishment in official correspondence.
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