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510(k) Data Aggregation
K Number
K250514Device Name
UPT Series Medical RO Water Treatment System
Manufacturer
Date Cleared
2025-03-17
(24 days)
Product Code
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
Specialty Water Technologies, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
UPT Series Medical Reverse Osmosis Water Treatment System is intended to be used to remove organic and inorganic contaminants from a tap water supply to dilute a dialysate concentrate for hemodialysis treatments, as well as for use for dialyzer reprocessing and dialysis equipment disinfecting and rinsing.
This System is for multi patient use, such as for a dialysis clinic or hospital serving multiple patients with a Central Water Purification System.
Device Description
The UPT Series Medical Reverse Osmosis Water Treatment System and its components consisting of; pretreatment, reverse osmosis, post-treatment, and the product water distribution components, are designed to remove microbiological, organic, and inorganic contaminants from the tap water to supply dialysis machines for the preparation of dialysate solutions for hemodialysis treatments.
Pretreatment components can include a tap water boosting system, blending valve, sediment filtration, carbon removal filters, water softeners, and all the necessary interconnecting plumbing. The purpose of this part of the system is to ensure that properly conditioned water is supplied to the reverse osmosis machine to ensure its safe and trouble-free operation.
After the tap water has been pre-treated, it then enters the R.O. (reverse osmosis), where total dissolved solids are removed to pertinent water quality standards. This is accomplished by utilizing a membrane separation process, whereby the incoming water is separated into a product stream, and a concentrate stream. The molecular weight cut-off determines what and how many contaminants are passed through into the product stream. R.O.s used for this application typically remove 95-99% of all total dissolved solids and bacteria.
The post treatment and product water distribution part of the system is in place to store, provide additional purification if needed, and deliver the purified water to wherever needed. These components can include items such as a storage tank, final filters (for bacteria and endotoxins), and delivery pumps and controls. Some systems can also utilize an ultraviolet light for additional disinfection properties if needed.
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K Number
K151637Device Name
UPT Series Medical RO Water System
Manufacturer
Date Cleared
2015-09-23
(98 days)
Product Code
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
Specialty Water Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
UPT Series Medical Reverse Osmosis Water Treatment System is intended to be used to remove organic and inorganic contaminants from a tap water supply to dilute a dialysate concentrate for hemodialysis treatments, as well as for use for dialyzer reprocessing and dialysis equipment disinfecting and rinsing.
This System is strictly for multi patient use, such as for a dialysis clinic or hospital serving multiple patients with a Central Water Purification System and is intended for use only with conventional hemodialysis treatments. It is not intended for use with high-flux, CRRT, or any other form of dialysis.
Device Description
The UPT Series Medical Reverse Osmosis Water Treatment System is an accessory device that is intended for use with hemodialysis applications and is intended to remove orqanic and inorganic substances and microbial contaminates from tap water used to dilute dialysis concentrate to form dialysate. The UPT Series Medical Reverse Osmosis Water Treatment System will produce water as prescribed by the Association for the Advancement of Medical Instrumentation (AAMI) Standard ANSI/AAMI/ISO 13959:2014 Water for Hemodialysis and Related Therapies provided adequate flow rate of the feed (tap) water and compliance with existing drinking water standards and proper pre-treatment.
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