DeviceClearance

Product code KOC— Gastroenterology, Urology

CAPILLARY FLOW DIALYZERS

Classification name
Accessories, Blood Circuit, Hemodialysis
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Total cleared
182
First cleared
Most recent

Market context for product code KOC

FDA has cleared 182 devices under product code KOC between 1976 and 2025, filed by 76 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code KOC

Adverse events under product code KOC

product code KOC
Death
4
Total
4

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code KOC

1–100 of 182

Data sourced from openFDA. This site is unofficial and independent of the FDA.