HEMODIALYSIS BLOOD TUBING SET— 510(k) K920797

Name: FDA 510(k) clearance K920797
Creator: U.S. Food and Drug Administration
Published: 1992-09-21

Substantially Equivalent

National Medical Care, Medical Products Div., Inc.

FDA 510(k) clearance K920797 for HEMODIALYSIS BLOOD TUBING SET, Substantially Equivalent on 1992-09-21. Applicant: National Medical Care, Medical Products Div., Inc.. Device class: 2.

Clearance details

Applicant: National Medical Care, Medical Products Div., Inc.
Product code: Code FJK
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1992-02-21
Decision date: 1992-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockleigh, NJ, US

Download summary PDF View on FDA.gov ↗

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K243607 — Moda-flx Hemodialysis System Cartridge (102121-001 )2024-12-20
K213992 — CombiSet Hemodialysis Blood Tubing Set2023-05-31

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K952343 — FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER1995-12-22
K930843 — RAPID DISCONNECT Y-SET, CAT. NO. 48-70001994-08-31
K914790 — HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R1993-03-05

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.