Cleared Special

UPT Series Medical RO Water Treatment System

K250514 · Specialty Water Technologies, Inc. · Gastroenterology & Urology

Mar 2025

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K250514 is an FDA 510(k) clearance for the UPT Series Medical RO Water Treatment System, a Subsystem, Water Purification (Class II — Special Controls, product code FIP), submitted by Specialty Water Technologies, Inc. (Portland, US). The FDA issued a Cleared decision on March 17, 2025, 24 days after receiving the submission on February 21, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5665.

Submission Details

510(k) Number	K250514 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 2025
Decision Date	March 17, 2025
Days to Decision	24 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF