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Data / Medical devices / Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Dialysate Concentrate For Hemodialysis (Liquid Or Powder) (KPO): 25 FDA-registered makers in 8 countries

25 establishments in 8 countries are registered with the FDA to make Dialysate Concentrate For Hemodialysis (Liquid Or Powder) (product code KPO, Class 2, 21 CFR 876.5820). 23 of them have a 510(k) clearance or PMA approval on file and 7 have a recall event. The FDA has issued 124 510(k) clearances under this code, the latest on August 19, 2026, and lists 45 recall events (3 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
KPO
Device class
2
Regulation
876.5820
Medical specialty
Gastroenterology, Urology
Life sustaining or supporting
Yes

Makers by country

CountryMakers
United States13
Mexico3
Italy3
Germany2
India1
Canada1
Ireland1
France1

Makers of Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Fresenius Medical Care Renal Therapies Group, LLCWaltham, MA, United StatesComplaint file establishment, Specification developer10January 29, 20260252api.fda.gov
Di-Chem, Inc.Champlin, MN, United StatesContract manufacturer, Manufacturer, Specification developer6August 12, 2022000api.fda.gov
Diasol IncPhoenix, AZ, United StatesManufacturer5February 10, 2014030api.fda.gov
Fresenius USA Manufacturing, Inc.Irving, TX, United StatesManufacturer5January 29, 2026000api.fda.gov
Nipro Renal Solutions USA, CorporationLewisberry, PA, United StatesManufacturer5August 4, 2023031api.fda.gov
Rockwell MedicalGrapevine, TX, United StatesComplaint file establishment, Manufacturer5March 3, 2023020api.fda.gov
Rockwell MedicalWixom, MI, United StatesComplaint file establishment, Manufacturer5March 3, 2023010api.fda.gov
B. Braun Avitum AGGLANDORF Lower Saxony, GermanyContract manufacturer, Manufacturer4April 25, 2011000api.fda.gov
Fresenius USA Manufacturing, Inc.Oregon, OH, United StatesManufacturer4January 29, 2026000api.fda.gov
Nxstage Medical, Inc.Lawrence, MA, United StatesComplaint file establishment, Specification developer3January 18, 2024070api.fda.gov
Vantive Healthcare Technologies Private LimitedBangalore Karnataka, IndiaSpecification developer3January 6, 2017000api.fda.gov
Baxter S.A. De C.V.Civac, Jiutepec, Morelos, MexicoManufacturer2January 6, 2017000api.fda.gov
Bieffe Medital S.p.A.SONDALO (SO) Sondrio, ItalyManufacturer2January 6, 2017000api.fda.gov
Fresenius Medical Care Deutschland GMBHST. WENDEL Saarland, GermanyManufacturer2September 9, 2025000api.fda.gov
Fresenius Medical Care de MexicoZapopan Jalisco, MexicoContract manufacturer, Manufacturer2September 9, 2025000api.fda.gov
Gambro Dasco S.P.A., Blood Line DivisionMEDOLLA Modena, ItalyExporter to the US, Manufacturer2February 4, 2008000api.fda.gov
Isopure, Corp.Louisville, KY, United StatesManufacturer2January 22, 2020030api.fda.gov
Rockwell MedicalWashington, IA, United StatesManufacturer2January 3, 2003000api.fda.gov
Fresenius USA Manufacturing, Inc.Knoxville, TN, United StatesManufacturer, Specification developer1May 18, 2017000api.fda.gov
Haemopharm Biofluids SRLTovo di S.Agata Sondrio, ItalyManufacturer1July 23, 2021000api.fda.gov
Haemotec, a division of Fresenius Medical Care Canada Inc.VAUDREUIL-DORION Quebec, CanadaManufacturer1May 12, 2022000api.fda.gov
Renal Care Dialysis Solutions, S.A. De C.V.El Marques Queretaro, MexicoManufacturer1March 3, 2023000api.fda.gov
Vantive Manufacturing LimitedCASTLEBAR, COUNTY MAYO Connaught, IrelandManufacturer1February 4, 2008000api.fda.gov
Evoqua Water Technologies LLCMinneapolis, MN, United StatesManufacturer0000api.fda.gov
S.M.A.D.L'ARBRESLE Rhone, FranceContract manufacturer0000api.fda.gov

Updated August 19, 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.