Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003768032

FEI Number

3013942511

Entity Name

ISOPURE, CORP.

City/State/Country

Louisville, KY, US

Establishment Address

12500 Westport Rd., 12540 Westport Rd., Louisville, KY 40245, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ISOPURE CORP. (Owner Number: 9042051)

Owner / Operator Contact Address

11851 Plantside Drive, --, Louisville, KY 40299, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K041163

PMA Number

N/A

All Registered Proprietary Names

MD420/440/460/470/480/490 Reverse O MD-100 Mobile Water Purification Sy Isopure ACDS (Acidified Concentrate Distribution and Storage) Isocube Aqua Caddy Isopure Complete Water System for H

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2008-12-01
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2008-12-01
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2012-12-13
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2007-10-09

Official Correspondent

KEVIN GILLESPIE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ISOPURE CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0033-2012	Isopure Corp	2	Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012, 5102131101 & 5113091012. Manufactured by: Isopure Corp, Simpsonville, KY System is used to mix and distribute bicarbonate as a part of a clinical dialysis system.
Z-0004-05	Ameriwater Inc	2	AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.

Similar Registrations

Registration Number	Establishment Name	Location
3010867648	NELSON ENVIRONMENTAL TECHNOLOGIES, INC.	Arlington, TX, US
2135346	CULLIGAN SOFT WATER SERVICE CO.	Minnetonka, MN, US
3015349756	DIALITY, INC.	Irvine, CA, US
3003550196	Veolia Water Treatment & Solutions	ARLINGTON, TX, US
9611824	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	SCHWEINFURT Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003768032. Last updated year: 2026. Please use registration number 3003768032 when referencing this establishment in official correspondence.