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FDA 510(k)

UPT Series Medical RO Water Treatment System

K-Number: K250514 · 2025-03-17

ApplicantSpecialty Water Technologies, Inc.
Decision Date2025-03-17
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UPT Series Medical RO Water Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Water Technologies, Inc.. It received FDA 510(k) clearance on 2025-03-17 under 510(k) number K250514. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UPT Series Medical RO Water Treatment System?

UPT Series Medical RO Water Treatment System is a medical device that received FDA 510(k) clearance on 2025-03-17. The listed applicant is Specialty Water Technologies, Inc.. The 510(k) number is K250514.

When did UPT Series Medical RO Water Treatment System receive FDA 510(k) clearance?

UPT Series Medical RO Water Treatment System received FDA 510(k) clearance on 2025-03-17, under 510(k) number K250514.

Who is the listed applicant for UPT Series Medical RO Water Treatment System?

The FDA 510(k) record lists Specialty Water Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UPT Series Medical RO Water Treatment System?

The FDA product code for UPT Series Medical RO Water Treatment System is FIP.

Related Devices (Code: FIP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLCK251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLCK252181AquaAFresenius Medical Care North AmericaK232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLCK223479AQUAbase nXB.Braun Medical, Inc.K231410RenaPure Endotoxin Retentive FilterEvoqua Water Technologies, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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