Isopure Corp
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 5
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1739-2022 | Class II | Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution | July 26, 2022 |
| Z-1360-2022 | Class II | Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) | April 28, 2022 |
| Z-0821-2020 | Class II | Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifug | April 19, 2019 |
| Z-0822-2020 | Class II | Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centri | April 19, 2019 |
| Z-0823-2020 | Class II | Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part) | April 19, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K191093 | Isopure Dry Acid Dissolution System | January 22, 2020 |
| K120005 | ACDS | March 29, 2012 |
| K112427 | BICARB MIXING AND DISTRIBUTION SYSTEM | January 26, 2012 |
| K041163 | ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES | October 7, 2004 |
| K993200 | MD 420/440/460/470/480/490 | January 24, 2000 |