FRESENIUS DISPOSABLE BLOOD LINES— 510(k) K853851

Name: FDA 510(k) clearance K853851
Creator: U.S. Food and Drug Administration
Published: 1985-11-12

Substantially Equivalent

Seratronics, Inc.

FDA 510(k) clearance K853851 for FRESENIUS DISPOSABLE BLOOD LINES, Substantially Equivalent on 1985-11-12. Applicant: Seratronics, Inc.. Device class: 2.

Clearance details

Applicant: Seratronics, Inc.
Product code: Code FJK
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1985-09-16
Decision date: 1985-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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K923529 — DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES1994-08-29
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Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.