510(k) K250514

UPT Series Medical RO Water Treatment System by Specialty Water Technologies, Inc. — Product Code FIP

K250514 is an FDA 510(k) premarket notification submitted by Specialty Water Technologies, Inc. for the device "UPT Series Medical RO Water Treatment System". The FDA issued a decision of Substantially Equivalent on March 17, 2025. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Specialty Water Technologies, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2025
Date Received
February 21, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type