# Isopure, Corp.

- Location (FDA's records): Simpsonville, KY
- FDA decisions: 5 (2000–2020): 5 510(k) clearances
- Product codes: FIP (2), KPO (2), FIN (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pure Water, Inc.: 2 (https://510kreport.com/company/pure-water)
- International Purification Systems, Inc.: 1 (https://510kreport.com/company/international-purification-systems)
- Fresenius Medical Care North America: 1 (https://510kreport.com/company/fresenius-medical-care-north-america)

## Firms that cite its devices most
- Better Water, Inc.: 3 (https://510kreport.com/company/better-water)
- Specialty Water Technologies: 2 (https://510kreport.com/company/specialty-water-technologies)
- Nipro Technical Solutions, Incoporated: 1 (https://510kreport.com/company/nipro-technical-solutions-incoporated)

## Its most-cited devices
- K041163: Isopure Complete Water System for Hemodialysis, MD 400 and MD 600 Series (2004), cited by 4
- K993200: MD 420/440/460/470/480/490 (2000), cited by 1
- K191093: Isopure Dry Acid Dissolution System (2020), cited by 1

## Recent decisions
- K191093: Isopure Dry Acid Dissolution System (Jan 22, 2020)
- K120005: ACDS (Mar 29, 2012)
- K112427: Bicarb Mixing and Distribution System (Jan 26, 2012)
- K041163: Isopure Complete Water System for Hemodialysis, MD 400 and MD 600 Series (Oct 7, 2004)
- K993200: MD 420/440/460/470/480/490 (Jan 24, 2000)

Source page: https://510kreport.com/company/isopure