SPECIALTY WATER TECHNOLOGIES, INC.

FDA Device Registration & Listing · Portland, TN, US · Registration 3012119281

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012119281
FEI Number
3012119281
Entity Name
SPECIALTY WATER TECHNOLOGIES, INC.
City/State/Country
Portland, TN, US
Establishment Address
104 Flex Ave, Portland, TN 37148, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Specialty Water Technologies, Inc. (Owner Number: 10050005)
Owner / Operator Contact Address
104 Flex Ave, Portland, TN 37148, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K151637
PMA Number
N/A

All Registered Proprietary Names

UPT Series Medical RO Water System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2025-03-24
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2015-10-05

Official Correspondent

Alex Clark

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Specialty Water Technologies, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K110578 Mar Cor Purification, Inc. MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM 2011-05-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-05 Ameriwater Inc 2
AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.

Similar Registrations

Registration Number Establishment Name Location
3010867648 NELSON ENVIRONMENTAL TECHNOLOGIES, INC. Arlington, TX, US
2135346 CULLIGAN SOFT WATER SERVICE CO. Minnetonka, MN, US
3015349756 DIALITY, INC. Irvine, CA, US
3003550196 Veolia Water Treatment & Solutions ARLINGTON, TX, US
9611824 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH SCHWEINFURT Bavaria, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012119281. Last updated year: 2026. Please use registration number 3012119281 when referencing this establishment in official correspondence.
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