DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS— 510(k) K082400

Name: FDA 510(k) clearance K082400
Creator: U.S. Food and Drug Administration
Published: 2009-02-03

Substantially Equivalent

Culligan Soft Water Service Co.

FDA 510(k) clearance K082400 for DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS, Substantially Equivalent on 2009-02-03. Applicant: Culligan Soft Water Service Co.. Device class: 2.

Clearance details

Applicant: Culligan Soft Water Service Co.
Product code: Code FIP
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 2008-08-20
Decision date: 2009-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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K252181 — AquaA2025-09-09
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K232953 — AquaBplus; AquaB LITE2024-06-13

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.