FDA.reportPublic FDA data

510(k) K252181

Device
AquaA
Applicant
Fresenius Medical Care North America
510(k) number
K252181
Product code
FIP
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-09
Date received
2025-07-11
Regulation
876.5665
Classification name
Subsystem, Water Purification
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Greg Calder
Address
920 Winter St. Waltham MA US 02451 02451

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
K250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.2025-03-17
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