510(k) clearance

Nipro Dry Acid Concentrate Mixer

FDA 510(k) source

510(k) number

K260799

Applicant

Nipro Technical Solutions, Incoporated

Decision date

Aug 19, 2026

Date received

Mar 11, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

KPO

Device type

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Device class

Class II

Regulation

21 CFR 876.5820

Advisory committee

Gastroenterology, Urology

Statement or summary

Summary

Third party

N

Location

Mesa, AZ, US