Isopure Corp
Louisville, KY, US
ISOPURE, CORP. appears in FDA device records in Louisville, KY. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Isopure Corp between 2000 and 2020. The busiest year on record is 2012, with 2. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2004 | 1 |
| 2012 | 2 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K191093 | Isopure Dry Acid Dissolution System | KPO | Substantially Equivalent | |
| K120005 | ACDS | KPO | Substantially Equivalent | |
| K112427 | BICARB MIXING AND DISTRIBUTION SYSTEM | FIN | Substantially Equivalent | |
| K041163 | ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES | FIP | Substantially Equivalent | |
| K993200 | MD 420/440/460/470/480/490 | FIP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003768032 | 3013942511 | ISOPURE, CORP. | 12500 Westport Rd., Louisville, KY 40245 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1739-2022 | 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 concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262 | Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching | Class II | Terminated | |
| Z-1360-2022 | 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. | Class II | Open, Classified | |
| Z-0823-2020 | Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part) | 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. | Class II | Terminated | |
| Z-0822-2020 | Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) 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. | Class II | Terminated | |
| Z-0821-2020 | 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. | Class II | Terminated | |
| Z-0190-2012 | 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 Isopure MD400 Series Reverse Osmosis System. Step | The cleaning solution Step 2, 3000-22000 GPD labeled bottles (NaOH) were filled with Step 1, 3000-22000 GPD chemical (HCl). | Terminated | ||
| Z-0033-2012 | 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. | Software problem causes transfer line between mixing and storage tank to not be rinsed after disinfection, leaving residual chlorine in the line. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain