HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD— 510(k) K852955

Name: FDA 510(k) clearance K852955
Creator: U.S. Food and Drug Administration
Published: 1986-02-05

Substantially Equivalent

Renalchem, Inc.

FDA 510(k) clearance K852955 for HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD, Substantially Equivalent on 1986-02-05. Applicant: Renalchem, Inc.. Device class: 2.

Clearance details

Applicant: Renalchem, Inc.
Product code: Code KPO
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1985-07-11
Decision date: 1986-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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K243786 — Bicarby Dialysate RFP-402 (RFP-402-G) +7 more2025-04-04
K240920 — HemoCare Bicarbonate Concentrate Set (BCS)2024-07-12

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.