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The Tracker / August 2026 / K260799

510(k) cleared

Nipro Dry Acid Concentrate Mixer

Nipro Technical Solutions, Incoporated · Aug 19, 2026 · K260799

FDA cleared the Nipro Dry Acid Concentrate Mixer from Nipro Technical Solutions, Incoporated on Aug 19, 2026 under K260799, a traditional 510(k). The device falls under product code KPO, Dialysate Concentrate For Hemodialysis (Liquid Or Powder), regulated at 21 CFR 876.5820 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Mar 11, 2026. The decision came 161 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Nipro Technical Solutions, Incoporated in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260799?

K260799 is the FDA 510(k) for Nipro Dry Acid Concentrate Mixer, submitted by Nipro Technical Solutions, Incoporated. FDA's decision date was Aug 19, 2026, under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)).

Who makes the Nipro Dry Acid Concentrate Mixer?

Nipro Technical Solutions, Incoporated, based in Mesa, AZ, is the applicant of record for K260799.

How long did the K260799 review take?

FDA received the submission on Mar 11, 2026 and issued its decision on Aug 19, 2026, 161 days later.

← All decisions in August 2026