BICARBONATE CONCENTRATE POWDER— 510(k) K891921

Name: FDA 510(k) clearance K891921
Creator: U.S. Food and Drug Administration
Published: 1989-04-17

Substantially Equivalent

Haemolyte, Inc.

FDA 510(k) clearance K891921 for BICARBONATE CONCENTRATE POWDER, Substantially Equivalent on 1989-04-17. Applicant: Haemolyte, Inc.. Device class: 2.

Clearance details

Applicant: Haemolyte, Inc.
Product code: Code KPO
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1989-03-27
Decision date: 1989-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nashville, TN, US

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Recent devices under product code KPO

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K260799 — Nipro Dry Acid Concentrate Mixer2026-08-19
K253462 — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)2026-01-29
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

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.