Data / Medical devices / United States / Isopure, Corp.

Isopure, Corp.: FDA-registered device maker in Louisville, KY, United States, 6 510(k) clearances

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

Isopure, Corp. is registered with the FDA (registration 3003768032) in Louisville, KY, United States. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 22, 2020. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Isopure, Corp.

FDA registration number: 3003768032
FEI number: 3013942511
Address: 12500 Westport Rd. 12540 Westport Rd., Louisville, KY, United States, 40245
Owner or operator: ISOPURE CORP. (9042051)
Roles: Manufacturer
First device listed: October 9, 2007
Registered through: 2026
Brand names listed: Aqua Caddy, Isocube, Isopure ACDS (Acidified Concentrate Distribution and Storage), Isopure Complete Water System for H, Isopure Dry Acid Dissolution System, Isopure Dry Acid Dissolution System, Acid Dissolution System, Accumix, Isopure Sodium Bicarbonate Mixing and Distribution System, MD-100 Mobile Water Purification Sy and more

Devices it lists

Device	Product code	Class	Role	Source
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	KPO	2	Manufacturer	accessdata.fda.gov
Subsystem, Water Purification	FIP	2	Manufacturer	accessdata.fda.gov
Tank, Holding, Dialysis	FIN	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 22, 2020	K191093	Isopure Dry Acid Dissolution System	KPO	Substantially Equivalent	Isopure, Corp.	accessdata.fda.gov
March 29, 2012	K120005	ACDS	KPO	Substantially Equivalent	Isopure, Corp.	accessdata.fda.gov
January 26, 2012	K112427	BICARB MIXING AND DISTRIBUTION SYSTEM	FIN	Substantially Equivalent	Isopure, Corp.	accessdata.fda.gov
October 7, 2004	K041163	ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES	FIP	Substantially Equivalent	Isopure, Corp.	accessdata.fda.gov
January 24, 2000	K993200	MD 420/440/460/470/480/490	FIP	Substantially Equivalent	Isopure, Corp.	accessdata.fda.gov
October 29, 1986	K863720	HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES	FIP	Substantially Equivalent	Water Pure, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 26, 2022	90739	Class II	Terminated	Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid	Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching	accessdata.fda.gov
April 28, 2022	90389	Class II	Ongoing	Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)	Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some of the device components. The firm is alerting customers to electrical safety measures that can be taken to prevent such events from occurring.	accessdata.fda.gov
April 19, 2019	83990	Class II	Terminated	Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3	There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause uneven wear during use, cause exposure of the magnet to solution, and thereby result in corrosion and the presence of iron.	accessdata.fda.gov
October 24, 2011	60366	Not yet classified	Terminated	Step 2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution. 4 oz plastic bottle. Lot # 11IC002, Serial #'s: 11IC00210 - 11IC002294. The Step 2, 3000-2000 GPD chemical is used in the cleaning procedures for the Isop	The cleaning solution Step 2, 3000-22000 GPD labeled bottles (NaOH) were filled with Step 1, 3000-22000 GPD chemical (HCl).	accessdata.fda.gov
May 19, 2011	59879	Not yet classified	Terminated	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 & 51130	Software problem causes transfer line between mixing and storage tank to not be rinsed after disinfection, leaving residual chlorine in the line.	accessdata.fda.gov

Compare with other makers

Updated September 13, 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.