# K250514: UPT Series Medical RO Water Treatment System

- Pathway: 510(k) (Special)
- Applicant: Specialty Water Technologies, Inc.
- Decided: Mar 17, 2025 after 24 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K944385 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151637: UPT Series Medical RO Water System, Specialty Water Technologies (2015) Summary page 5.
- K041163: Isopure Complete Water System for Hemodialysis, MD 400 and MD 600 Series, Isopure, Corp. (2004) Summary page 5.

## Indications for 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.

Source page: https://510kreport.com/device/K250514
Methodology: https://510kreport.com/methodology