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FDA 510(k)

Nipro Dry Acid Concentrate Mixer

K-Number: K260799 · 2026-08-19

ApplicantNipro Technical Solutions, Incoporated
Decision Date2026-08-19
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Nipro Dry Acid Concentrate Mixer is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Technical Solutions, Incoporated. It received FDA 510(k) clearance on 2026-08-19 under 510(k) number K260799. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nipro Dry Acid Concentrate Mixer?

Nipro Dry Acid Concentrate Mixer is a medical device that received FDA 510(k) clearance on 2026-08-19. The listed applicant is Nipro Technical Solutions, Incoporated. The 510(k) number is K260799.

When did Nipro Dry Acid Concentrate Mixer receive FDA 510(k) clearance?

Nipro Dry Acid Concentrate Mixer received FDA 510(k) clearance on 2026-08-19, under 510(k) number K260799.

Who is the listed applicant for Nipro Dry Acid Concentrate Mixer?

The FDA 510(k) record lists Nipro Technical Solutions, Incoporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nipro Dry Acid Concentrate Mixer?

The FDA product code for Nipro Dry Acid Concentrate Mixer is KPO.

Related Devices (Code: KPO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLCK252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)Fresenius Medical Care Renal Therapies Group, LLCK243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)Fresenius Medical Care Renal Therapies Group, LLCK240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and DevelopmentK233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)Fresenius Medical Care Renal Therapies Group, LLCK233213NxStage PureFlow SolutionNxstage Medical, Inc.

Official Source

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