Diasol, Inc
FDA Regulatory Profile
Diasol, Inc appears in FDA public data with 8 recalls, 10 510(k) clearances, 13 FDA inspections, and 4 compliance actions on record. Its most recent recall (Z-0989-2026, Class II) was initiated on November 5, 2025. Its most recent 510(k) clearance was granted on February 10, 2014.
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 10
- Inspections
- 13
- Compliance Actions
- 4
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0989-2026 | Class II | Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non | November 5, 2025 |
| Z-0992-2026 | Class II | Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non | November 5, 2025 |
| Z-0990-2026 | Class II | Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non | November 5, 2025 |
| Z-0987-2026 | Class II | Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non | November 5, 2025 |
| Z-0988-2026 | Class II | Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non | November 5, 2025 |
| Z-0991-2026 | Class II | Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non | November 5, 2025 |
| Z-0207-2025 | Class II | Diasol Acid Concentrate REF G100325-10Dex 100 | July 27, 2022 |
| Z-2402-2020 | Class II | DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS | April 30, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K130511 | CITRISOL ACID CONCENTRATE | February 10, 2014 |
| K020231 | DIASOL-ADDITIVES | October 21, 2002 |
| K020230 | DIASOL-BICARB | April 23, 2002 |
| K011004 | NEEDLELOK HYPODERMIC NEEDLE PROTECTION | May 24, 2001 |
| K010958 | FISTULOK FISTULA NEEDLE PROTECTION | May 18, 2001 |
| K011003 | SAFESTING AND SAFESTING HUB | April 20, 2001 |
| K992999 | DAISY PROTECTED SCALP VEIN SET | November 5, 1999 |
| K993187 | SHELLY PROTECTED AV FISTULA NEEDLE | November 5, 1999 |
| K992653 | SHELLY PROTECTED AV FISTULA NEEDLE | October 27, 1999 |
| K993212 | DRYASOL ACID CONCENTRATE MIX | October 22, 1999 |