Nipro Renal Solutions USA, Corporation

FDA Device Registration & Listing · LEWISBERRY, PA, US · Registration 1528807

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
1528807
FEI Number
1000142899
Entity Name
Nipro Renal Solutions USA, Corporation
City/State/Country
LEWISBERRY, PA, US
Establishment Address
509 Fishing Creek Rd, LEWISBERRY, PA 17339, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Nipro Renal Solutions USA, Corp (Owner Number: 10035998)
Owner / Operator Contact Address
509 Fishing Creek Road, Lewisberry, PA 17339, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K171750
PMA Number
N/A

All Registered Proprietary Names

MedicaLyte Citric Complete

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 2014-06-03
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2018-07-25

Official Correspondent

Ennis Xhepa

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nipro Renal Solutions USA, Corp
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1528807. Last updated year: 2026. Please use registration number 1528807 when referencing this establishment in official correspondence.
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