510(k) K851431 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
HEMODIALYSIS CONCENTRATE ADDITIVES
| Applicant | Dana Laboratories, Costa Mesa CA, US |
| Decision | Substantially Equivalent, Jun 12, 1985 |
| Received | Apr 10, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851431
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Oct 23, 2024 | Diasol, Inc Diasol Acid Concentrate REF G100325-10Dex 100 Open, Classified |
KPO | None listed |
| Apr 30, 2020 | Diasol, Inc DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS Terminated |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.