510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Diasol, Inc

Phoenix, AZ, US

DIASOL INC appears in FDA device records in Phoenix, AZ. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
10
PMA records
0
Recall records
8
Registered establishments
1

510(k) clearance history

FDA records hold 10 510(k) clearances for Diasol, Inc between 1999 and 2014. The busiest year on record is 1999, with 4. The most recent is 2014, with 1.

Clearances by year, as a table
510(k) clearance decisions for Diasol, Inc, by decision year
YearClearances
19994
20013
20022
20141
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K130511CITRISOL ACID CONCENTRATEKPOSubstantially Equivalent
K020231DIASOL-ADDITIVESKPOSubstantially Equivalent
K020230DIASOL-BICARBKPOSubstantially Equivalent
K011004NEEDLELOK HYPODERMIC NEEDLE PROTECTIONFMISubstantially Equivalent
K010958FISTULOK FISTULA NEEDLE PROTECTIONFMISubstantially Equivalent
K011003SAFESTING AND SAFESTING HUBFPASubstantially Equivalent
K993187SHELLY PROTECTED AV FISTULA NEEDLEFPASubstantially Equivalent
K992999DAISY PROTECTED SCALP VEIN SETFPASubstantially Equivalent
K992653SHELLY PROTECTED AV FISTULA NEEDLEFIESubstantially Equivalent
K993212DRYASOL ACID CONCENTRATE MIXKPOSubstantially Equivalent

Registered establishments

FDA registered establishments for Diasol, Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30071374823007137482DIASOL INC310 S 43RD AVE, Phoenix, AZ 85009 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0992-2026Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 litersSafety and efficacy of dialysis acid concentrate cannot be assuredClass IIOpen, Classified
Z-0991-2026Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 litersSafety and efficacy of dialysis acid concentrate cannot be assuredClass IIOpen, Classified
Z-0990-2026Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 litersSafety and efficacy of dialysis acid concentrate cannot be assuredClass IIOpen, Classified
Z-0989-2026Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 litersSafety and efficacy of dialysis acid concentrate cannot be assuredClass IIOpen, Classified
Z-0988-2026Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 litersSafety and efficacy of dialysis acid concentrate cannot be assuredClass IIOpen, Classified
Z-0987-2026Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 litersSafety and efficacy of dialysis acid concentrate cannot be assuredClass IIOpen, Classified
Z-0207-2025Diasol Acid Concentrate REF G100325-10Dex 100Due 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.Class IIOpen, Classified
Z-2402-2020DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSISIncorrect labeling of dialysate concentration for hemodialysis.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain