Consumer health companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Isopure with 5 510(k) clearances and 5 device recalls. The most recent is a device recall dated Jul 26, 2022: Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate D….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 26, 2022 | Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intendeClass II · Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching | Device recalls |
| Apr 28, 2022 | Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)Class II · Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resu | Device recalls |
| Jan 22, 2020 | Isopure Dry Acid Dissolution SystemK191093 · KPO | 510(k) clearances |
| Apr 19, 2019 | Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3Class II · There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial | Device recalls |
| Apr 19, 2019 | Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3Class II · There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial | Device recalls |
| Apr 19, 2019 | Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)Class II · There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial | Device recalls |
| Mar 29, 2012 | ACDSK120005 · KPO | 510(k) clearances |
| Jan 26, 2012 | BICARB MIXING AND DISTRIBUTION SYSTEMK112427 · FIN | 510(k) clearances |
| Oct 7, 2004 | ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIESK041163 · FIP | 510(k) clearances |
| Jan 24, 2000 | MD 420/440/460/470/480/490K993200 · FIP | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
