Nipro Dry Acid Concentrate Mixer— 510(k) K260799
Substantially EquivalentNipro Technical Solutions, Incoporated
FDA 510(k) clearance K260799 for Nipro Dry Acid Concentrate Mixer, Substantially Equivalent on 2026-08-19. Applicant: Nipro Technical Solutions, Incoporated. Device class: 2.
Summary
Nipro Technical Solutions filed the Nipro Dry Acid Concentrate Mixer under product code KPO, dialysate concentrate for hemodialysis (liquid or powder). No model numbers are listed.
Class II, 21 CFR 876.5820. Gastroenterology and Urology is both the classification panel and the review panel. The submission was a Traditional 510(k).
Nipro filed from Mesa, Arizona. The decision came 161 calendar days after FDA received it (March 11 to August 19, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Nipro Technical Solutions, Incoporated
- Product code
- Product 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
- Mesa, AZ, US
Recent devices under product code KPO
view all- K253462 — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
- K252180 — Bicarby Dialysate RFP-404 (RFP-404-W) +7 more
- K243786 — Bicarby Dialysate RFP-402 (RFP-402-G) +7 more
- K240920 — HemoCare Bicarbonate Concentrate Set (BCS)
- K233950 — pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.