POWDERED BICARBONATE CONCENTRATE— 510(k) K865078

Name: FDA 510(k) clearance K865078
Creator: U.S. Food and Drug Administration
Published: 1987-03-27

Substantially Equivalent

Bicarbolyte Corp.

FDA 510(k) clearance K865078 for POWDERED BICARBONATE CONCENTRATE, Substantially Equivalent on 1987-03-27. Applicant: Bicarbolyte Corp.. Device class: 2.

Clearance details

Applicant: Bicarbolyte Corp.
Product code: Code KPO
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1986-12-29
Decision date: 1987-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottesville, VA, 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

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K843866 — HEMODIALYSATE SOLUTIONS1985-01-09

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.