DIALYSATE CONCENTRATE FOR HEMODIALYSIS— 510(k) K810280

Name: FDA 510(k) clearance K810280
Creator: U.S. Food and Drug Administration
Published: 1981-02-19

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K810280 for DIALYSATE CONCENTRATE FOR HEMODIALYSIS, Substantially Equivalent on 1981-02-19. Applicant: Cobe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code KPO
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1981-02-02
Decision date: 1981-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPO

view all

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

More clearances from Cobe Laboratories, Inc.

view all

K923272 — COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR1993-05-11
K900105 — COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC1991-03-22
K905793 — COBE CENTRY 2 BICART OPTION KIT1991-02-12
K905388 — COBE CENTRYSYSTEM 3 BICART OPTION KIT1991-02-11
K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR1990-12-27

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.