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Isopure, Corp.

Last updated September 17, 2026

Information

Country: US
Address: 12500 Westport Rd., Louisville, KY, 40245
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Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3013942511
DUNS Number: 040279650

Catalogue (16)

Device	Model / Reference	Registries	Class	Status
MD420 Reverse Osmosis System	MD420	FDA UDI	Class II	Active
MD460 Reverse Osmosis System	MD460	FDA UDI	Class II	Active
Complete Water Treatment System	001	FDA UDI	Class II	Active
Acid Dissolution System	MD70500	FDA UDI	Class II	Active
MD490 Reverse Osmosis System	MD490	FDA UDI	Class II	Active
Sodium Bicarbonate Mixing and Distribution System	IsoMix PRO	FDA UDI	Class II	Active
MD470 Reverse Osmosis System	MD470	FDA UDI	Class II	Active
Acidified Concentrate Distribution and Storage (ACDS) System	MD704262	FDA UDI	Class II	Active
Acid Dissolution System	MD70510	FDA UDI	Class II	Active
MD480 Reverse Osmosis System	MD480	FDA UDI	Class II	Active
MD440 Reverse Osmosis System	MD440	FDA UDI	Class II	Active
Md 420/440/460/470/480/490	K993200	FDA 510(k)	Class II	Active
Bicarb Mixing And Distribution System	K112427	FDA 510(k)	Class II	Active
Isopure Complete Water System For Hemodialysis, Md 400 And Md 600 Series	K041163	FDA 510(k)	Class II	Active
Acds	K120005	FDA 510(k)	Class II	Active
Isopure Dry Acid Dissolution System	K191093	FDA 510(k)	Class II	Active

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FDA Recalls (7)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 26, 2022	Z-1739-2022	—	terminated	Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching
Apr 28, 2022	Z-1360-2022	—	open, classified	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.
Apr 19, 2019	Z-0823-2020	—	terminated	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.
Apr 19, 2019	Z-0821-2020	—	terminated	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.
Apr 19, 2019	Z-0822-2020	—	terminated	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.
Oct 24, 2011	Z-0190-2012	—	terminated	The cleaning solution Step 2, 3000-22000 GPD labeled bottles (NaOH) were filled with Step 1, 3000-22000 GPD chemical (HCl).
May 19, 2011	Z-0033-2012	—	terminated	Software problem causes transfer line between mixing and storage tank to not be rinsed after disinfection, leaving residual chlorine in the line.