Company ยท US
Diasol, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2014. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
8recalls (6 in 12 months)
8recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 10, 2014 | K130511 | CITRISOL ACID CONCENTRATE Diasol, Inc. | KPO |
| Oct 21, 2002 | K020231 | DIASOL-ADDITIVES Diasol, Inc. | KPO |
| Apr 23, 2002 | K020230 | DIASOL-BICARB Diasol, Inc. | KPO |
| May 24, 2001 | K011004 | NEEDLELOK HYPODERMIC NEEDLE PROTECTION Diasol, Inc. | FMI |
| May 18, 2001 | K010958 | FISTULOK FISTULA NEEDLE PROTECTION Diasol, Inc. | FMI |
| Apr 20, 2001 | K011003 | SAFESTING AND SAFESTING HUB Diasol, Inc. | FPA |
| Nov 5, 1999 | K993187 | SHELLY PROTECTED AV FISTULA NEEDLE Diasol, Inc. | FPA |
| Nov 5, 1999 | K992999 | DAISY PROTECTED SCALP VEIN SET Diasol, Inc. | FPA |
| Oct 27, 1999 | K992653 | SHELLY PROTECTED AV FISTULA NEEDLE Diasol, Inc. | FIE |
| Oct 22, 1999 | K993212 | DRYASOL ACID CONCENTRATE MIX Diasol, Inc. | KPO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2025 | Diasol, Inc Brand Name: Diasol
Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters Open, Classified |
KPO | K851431 |
| Dec 23, 2025 | Diasol, Inc Brand Name: Diasol
Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters Open, Classified |
KPO | K851431 |
| Dec 23, 2025 | Diasol, Inc Brand Name: Diasol
Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters Open, Classified |
KPO | K851431 |
| Dec 23, 2025 | Diasol, Inc Brand Name: Diasol
Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters Open, Classified |
KPO | K851431 |
| Dec 23, 2025 | Diasol, Inc Brand Name: Diasol
Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters Open, Classified |
KPO | K851431 |
| Dec 23, 2025 | Diasol, Inc Brand Name: Diasol
Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters Open, Classified |
KPO | K851431 |
| Oct 23, 2024 | Diasol, Inc Diasol Acid Concentrate REF G100325-10Dex 100 Open, Classified |
KPO | K851431 |
| Apr 30, 2020 | Diasol, Inc DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS Terminated |
KPO | K851431 |