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FDA 510(k)

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis

K-Number: K193155 · 2020-11-25

ApplicantNipro Renal Solutions USA, Corp.
Decision Date2020-11-25
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Renal Solutions USA, Corp.. It received FDA 510(k) clearance on 2020-11-25 under 510(k) number K193155. 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 Complete Dry Acid Concentrate for Hemodialysis?

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis is a medical device that received FDA 510(k) clearance on 2020-11-25. The listed applicant is Nipro Renal Solutions USA, Corp.. The 510(k) number is K193155.

When did Nipro Dry Complete Dry Acid Concentrate for Hemodialysis receive FDA 510(k) clearance?

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis received FDA 510(k) clearance on 2020-11-25, under 510(k) number K193155.

Who is the listed applicant for Nipro Dry Complete Dry Acid Concentrate for Hemodialysis?

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

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

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

Other records listing Nipro Renal Solutions USA, Corp. as applicant

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.

K223431Citric Complete Liquid Citric Acid Concentrate

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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