ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1— 510(k) K852309

Name: FDA 510(k) clearance K852309
Creator: U.S. Food and Drug Administration
Published: 1985-07-26

Substantially Equivalent

Erika, Inc.

FDA 510(k) clearance K852309 for ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1, Substantially Equivalent on 1985-07-26. Applicant: Erika, Inc.. Device class: 2.

Clearance details

Applicant: Erika, Inc.
Product code: Code FJK
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1985-05-29
Decision date: 1985-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockleigh, NJ, US

Download summary PDF View on FDA.gov ↗

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K853134 — NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-81985-11-06
K852310 — NATURALYTE BICARBONATE CONCENTRATE-DRY PACK1985-07-26
K850865 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-1985-04-03
K850866 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L1985-04-03
K850654 — TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID1985-03-07

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.