HEMODIALYSIS CONCENTRATE ADDITIVES— 510(k) K851431
Substantially EquivalentDana Laboratories
FDA 510(k) clearance K851431 for HEMODIALYSIS CONCENTRATE ADDITIVES, Substantially Equivalent on 1985-06-12. Applicant: Dana Laboratories. Device class: 2.
Clearance details
- Applicant
- Dana Laboratories
- Product code
- Code KPO
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Costa Mesa, CA, US
Recent devices under product code KPO
view allMore clearances from Dana Laboratories
view allAdverse events under product code KPO
product code KPO- Death
- 14
- Malfunction
- 775
- Other
- 20
- Total
- 809
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K851431
K-number listed on FDA's recall record- Z-0987-2026 — Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
- Z-0988-2026 — Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
- Z-0989-2026 — Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
- Z-0990-2026 — Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
- Z-0991-2026 — Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
- Z-0992-2026 — Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
- Z-0207-2025 — Diasol Acid Concentrate REF G100325-10Dex 100
- Z-2402-2020 — DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K851431.
Data sourced from openFDA. This site is unofficial and independent of the FDA.