Data / Medical devices / United States / Diasol Inc

Diasol Inc: FDA-registered device maker in Phoenix, AZ, United States, 5 510(k) clearances

Name: Diasol Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Diasol Inc is registered with the FDA (registration 3007137482) in Phoenix, AZ, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 10, 2014. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007137482
Address: 310 S 43RD AVE No. B, Phoenix, AZ, United States, 85009
Owner or operator: DIASOL, INC. (9035798)
Roles: Manufacturer
First device listed: June 3, 2008
Registered through: 2026
Brand names listed: CitriSol concentrate, DIASOL ADDITIVES, DIASOL BICARB, Dia Chair, Diasol, diasol concentrate

Devices it lists

Device	Product code	Class	Role	Source
Chair, Dialysis, Unpowered, Without Scales	FIA	1	Manufacturer	accessdata.fda.gov
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	KPO	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 10, 2014	K130511	CITRISOL ACID CONCENTRATE	KPO	Substantially Equivalent	Diasol, Inc.	accessdata.fda.gov
October 21, 2002	K020231	DIASOL-ADDITIVES	KPO	Substantially Equivalent	Diasol, Inc.	accessdata.fda.gov
April 23, 2002	K020230	DIASOL-BICARB	KPO	Substantially Equivalent	Diasol, Inc.	accessdata.fda.gov
October 22, 1999	K993212	DRYASOL ACID CONCENTRATE MIX	KPO	Substantially Equivalent	Diasol, Inc.	accessdata.fda.gov
June 12, 1985	K851431	HEMODIALYSIS CONCENTRATE ADDITIVES	KPO	Substantially Equivalent	Dana Laboratories	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 5, 2025	97989	Class II	Ongoing	Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters	Safety and efficacy of dialysis acid concentrate cannot be assured	accessdata.fda.gov
July 27, 2022	95334	Class II	Ongoing	Diasol Acid Concentrate REF G100325-10Dex 100	Due to labeling issue. The box label is different that the gallon label in that gallon label shows a lower Calcium concentration than the box label.	accessdata.fda.gov
April 30, 2020	85695	Class II	Terminated	DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS	Incorrect labeling of dialysate concentration for hemodialysis.	accessdata.fda.gov

Compare with other makers

Updated December 23, 2025. 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.