SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS— 510(k) K863631

Name: FDA 510(k) clearance K863631
Creator: U.S. Food and Drug Administration
Published: 1986-10-16

Substantially Equivalent

American Healthcare Corp.

FDA 510(k) clearance K863631 for SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS, Substantially Equivalent on 1986-10-16. Applicant: American Healthcare Corp.. Device class: 2.

Clearance details

Applicant: American Healthcare Corp.
Product code: Code KPO
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1986-09-17
Decision date: 1986-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longmont, CO, US

Download summary PDF View on FDA.gov ↗

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K252180 — Bicarby Dialysate RFP-404 (RFP-404-W) +7 more2025-09-09
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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K923938 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER1993-06-17
K923939 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER1993-06-17
K923940 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE1993-06-17
K923941 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE1993-06-17

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.