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Data / Medical devices / Subsystem, Water Purification / United States

FDA-registered makers of Subsystem, Water Purification in the United States: 33 establishments

33 establishments in the United States are registered with the FDA to make Subsystem, Water Purification (product code FIP). 19 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 3, 2026.

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Device
Subsystem, Water Purification
Product code
FIP
Country
United States

Makers of Subsystem, Water Purification in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Evoqua Water Technologies LLCMinneapolis, MN, United StatesComplaint file establishment, Manufacturer, Specification developer19July 19, 2023030api.fda.gov
Ameriwater LLC.Dayton, OH, United StatesComplaint file establishment, Manufacturer10February 13, 2023020api.fda.gov
Fresenius Medical Care Renal Therapies Group, LLCWaltham, MA, United StatesComplaint file establishment, Specification developer6November 14, 2025060api.fda.gov
Isopure, Corp.Louisville, KY, United StatesManufacturer3October 7, 2004000api.fda.gov
Better Water, Inc.Smyrna, TN, United StatesManufacturer2January 24, 1996000api.fda.gov
Evoqua Water Technologies - JacksonvilleJacksonville, FL, United StatesManufacturer2December 22, 2000000api.fda.gov
Nephros, Inc.South Orange, NJ, United StatesComplaint file establishment, Contract manufacturer, Specification developer2March 2, 2017000api.fda.gov
Specialty Water Technologies, Inc.Portland, TN, United StatesManufacturer2March 17, 2025000api.fda.gov
BTI FiltrationOklahoma City, OK, United StatesManufacturer1June 2, 2008000api.fda.gov
Evoqua Water Technologies - MilpitasMilpitas, CA, United StatesManufacturer1December 22, 2000000api.fda.gov
Evoqua Water Technologies - South WindsorSouth Windsor, CT, United StatesManufacturer1December 22, 2000000api.fda.gov
Evoqua Water Technologies LLCIndianapolis, IN, United StatesManufacturer1December 22, 2000000api.fda.gov
Mesa Laboratories, Inc.Denver, CO, United StatesManufacturer1December 19, 1997000api.fda.gov
Nelson Environmental Technologies, Inc.Arlington, TX, United StatesManufacturer1May 25, 2000000api.fda.gov
Nelson Environmental Technologies, Inc.Stafford, TX, United StatesManufacturer1May 25, 2000000api.fda.gov
Nelson Environmental Technologies, Inc.Mc Allen, TX, United StatesManufacturer1May 25, 2000000api.fda.gov
Serim Research Corp.Elkhart, IN, United StatesManufacturer1August 9, 1995000api.fda.gov
Staubach Barror Water Systems Inc.Schenectady, NY, United StatesManufacturer1February 21, 2008000api.fda.gov
Veolia Water Treatment & SolutionsArlington, TX, United StatesManufacturer1January 2, 2001000api.fda.gov
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
B & G MFG. Co.Hatfield, PA, United StatesContract manufacturer0000api.fda.gov
Diality, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
First Article IncSouderton, PA, United StatesContract manufacturer0000api.fda.gov
Flex-Cell Precision, Inc.Lancaster, PA, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Fresenius USA Manufacturing, Inc.Oregon, OH, United StatesManufacturer0000api.fda.gov
Hach CompanyAmes, IA, United StatesManufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
J & J Precision Technologies, LLCLititz, PA, United StatesContract manufacturer0000api.fda.gov
J&B Precision, Inc.Cordova, TN, United StatesContract manufacturer0000api.fda.gov
Outset Medical, Inc.San Jose, CA, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Victoria Precision Inc.Trevose, PA, United StatesContract manufacturer0000api.fda.gov

Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.