FRESENIUS ULTRAFLUX HEMODIALYZER— 510(k) K031378

Name: FDA 510(k) clearance K031378
Creator: U.S. Food and Drug Administration
Published: 2003-05-30

Substantially Equivalent

Fresenius Medical Care North America

FDA 510(k) clearance K031378 for FRESENIUS ULTRAFLUX HEMODIALYZER, Substantially Equivalent on 2003-05-30. Applicant: Fresenius Medical Care North America. Device class: 2.

Clearance details

Applicant: Fresenius Medical Care North America
Product code: Code KDI
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 2003-05-01
Decision date: 2003-05-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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K253412 — Tablo Hemodialysis System (PN-0008000, PN-0006000U)2026-01-26

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K152953 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER2015-11-05
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K123262 — OPTIFLUX ULTRA DIALYZER2014-01-06

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

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.