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Diasol, Inc

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
10
Inspections
13
Compliance Actions
4

Recent Recalls

NumberClassProductDate
Z-0990-2026Class IIBrand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis NonNovember 5, 2025
Z-0992-2026Class IIBrand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis NonNovember 5, 2025
Z-0987-2026Class IIBrand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis NonNovember 5, 2025
Z-0988-2026Class IIBrand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis NonNovember 5, 2025
Z-0991-2026Class IIBrand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis NonNovember 5, 2025
Z-0989-2026Class IIBrand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis NonNovember 5, 2025
Z-0207-2025Class IIDiasol Acid Concentrate REF G100325-10Dex 100July 27, 2022
Z-2402-2020Class IIDIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSISApril 30, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K130511CITRISOL ACID CONCENTRATEFebruary 10, 2014
K020231DIASOL-ADDITIVESOctober 21, 2002
K020230DIASOL-BICARBApril 23, 2002
K011004NEEDLELOK HYPODERMIC NEEDLE PROTECTIONMay 24, 2001
K010958FISTULOK FISTULA NEEDLE PROTECTIONMay 18, 2001
K011003SAFESTING AND SAFESTING HUBApril 20, 2001
K992999DAISY PROTECTED SCALP VEIN SETNovember 5, 1999
K993187SHELLY PROTECTED AV FISTULA NEEDLENovember 5, 1999
K992653SHELLY PROTECTED AV FISTULA NEEDLEOctober 27, 1999
K993212DRYASOL ACID CONCENTRATE MIXOctober 22, 1999