RENAL SYSTEMS HEMODIALYSIS CONCENTRATE— 510(k) K792213

Name: FDA 510(k) clearance K792213
Creator: U.S. Food and Drug Administration
Published: 1980-01-04

Substantially Equivalent

Renal Systems, Inc.

FDA 510(k) clearance K792213 for RENAL SYSTEMS HEMODIALYSIS CONCENTRATE, Substantially Equivalent on 1980-01-04. Applicant: Renal Systems, Inc.. Device class: 2.

Clearance details

Applicant: Renal Systems, Inc.
Product code: Code KPO
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1979-11-02
Decision date: 1980-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K861730 — ACTRIL FOR KIDNEY MACHINE DISINFECTANT1987-06-09
K854011 — RENALFO HEMOFILTER CAVHD1985-11-05
K844790 — RENAFLO HEMOCONCENTRATOR1985-05-23
K843963 — DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD1985-01-07

Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

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.