FDA.reportPublic FDA data

510(k) K250514

Device
UPT Series Medical RO Water Treatment System
Applicant
Specialty Water Technologies, Inc.
510(k) number
K250514
Product code
FIP
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-17
Date received
2025-02-21
Regulation
876.5665
Classification name
Subsystem, Water Purification
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Alex Clark
Address
104 Flex Ave. Portland TN US 37148 37148

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FIP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLC2025-11-14
K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC2025-10-09
K252181AquaAFresenius Medical Care North America2025-09-09
K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLC2024-06-13
K223479AQUAbase nXB.Braun Medical, Inc.2023-08-16
K231410RenaPure Endotoxin Retentive FilterEvoqua Water Technologies, LLC2023-07-19
K223656AmeriWater MediQA Reverse Osmosis System (MSP3HF)AmeriWater, LLC2023-02-13
K213507AquaAFresenius Medical Care Rental Therapies Group, LLC2022-07-27
K211035U9000 Plus UltrafilterBaxter Healthcare Corporation2021-10-19
K200670EON Portable RO Water Purification SystemMar Cor Purification, Inc.2020-04-16
K192398Millenium HXMar Cor Purification, Inc.2019-10-03
K182367DIASAFEplusUSFresenius Medical Care Renal Therapies Group, LLC2019-01-10
K171099EON Portable Reverse Osmosis Water Purification SystemCantel2018-01-05
K161304EndoPur FilterNephros, Inc.2017-03-02
K161844Matrix Pre-Treatment ControllerBetter Water, LLC2016-12-13