ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES— 510(k) K041163

Name: FDA 510(k) clearance K041163
Creator: U.S. Food and Drug Administration
Published: 2004-10-07

Substantially Equivalent

Isopure, Corp.

FDA 510(k) clearance K041163 for ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES, Substantially Equivalent on 2004-10-07. Applicant: Isopure, Corp.. Device class: 2.

Clearance details

Applicant: Isopure, Corp.
Product code: Code FIP
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 2004-05-03
Decision date: 2004-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Simpsonville, KY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FIP

view all

K250471 — AquaC UNO H2025-11-14
K251851 — DIASAFEplusUS (F00013010)2025-10-09
K252181 — AquaA2025-09-09
K250514 — UPT Series Medical RO Water Treatment System2025-03-17
K232953 — AquaBplus; AquaB LITE2024-06-13

More clearances from Isopure, Corp.

view all

K191093 — Isopure Dry Acid Dissolution System2020-01-22
K120005 — ACDS2012-03-29
K112427 — BICARB MIXING AND DISTRIBUTION SYSTEM2012-01-26
K993200 — MD 420/440/460/470/480/4902000-01-24

Adverse events under product code FIP

product code FIP

Malfunction: 490
Total: 490

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.