← Back to catalogue

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis

FDA 510(k)

Class II (US FDA 510(k))

510(k) K193155

by Nipro Renal Solutions USA, Corporation

Identifiers

510(k) Number
K193155 FDA 510(k)
FDA Product Code
KPO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5820 FDA 510(k)
Regulation Number
876.5820 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Nipro Dry Complete Dry Acid Concentrate for Hemodialysis is a Dialysate Concentrate for Hemodialysis (Liquid or Powder) as classified under FDA regulation 876.5820. This powder-based concentrate is designed to prepare dialysate solutions used in hemodialysis, facilitating the removal of waste products and excess fluids from the blood of patients with end-stage renal disease.

Supplied as a dry powder, the concentrate is intended for single-use preparation by combining with a sterile diluent to form the final hemodialysis solution. It is regulated under FDA 510(k) clearance (K193155) and falls under Class II medical devices. The product is distributed in sterile packaging and must be handled in accordance with standard hemodialysis protocols to ensure proper functionality and patient safety.

Frequently asked questions

What is the Nipro Dry Complete Dry Acid Concentrate for Hemodialysis used for in clinical practice?

This product is a powder-based dialysate concentrate designed to prepare hemodialysis solutions, which remove waste products and excess fluids from the blood of patients with end-stage renal disease. It is specifically formulated to be mixed with a sterile diluent to create the final dialysis fluid, ensuring proper filtration and purification during the hemodialysis process.

How is the Nipro Dry Complete Dry Acid Concentrate for Hemodialysis supplied, and is it intended for single-use?

The concentrate is supplied as a dry powder in sterile packaging. It is explicitly intended for single-use only, meaning each package must be used once to prepare a hemodialysis solution before being discarded. This ensures patient safety and prevents contamination.

Are there multiple sizes or models of this product, and how should it be stored?

The provided data does not specify distinct sizes or models beyond the product name, but it is classified under FDA product code KPO for dialysate concentrates. Storage should follow standard hemodialysis protocols for dry powder concentrates—keep in a clean, dry environment, away from direct sunlight, and ensure the packaging remains intact until use to maintain sterility.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for users?

The Nipro Dry Complete Dry Acid Concentrate for Hemodialysis received FDA 510(k) clearance (K193155), meaning it was determined to be *substantially equivalent* to a legally marketed predicate device. This clearance confirms it meets FDA safety and effectiveness standards for dialysate concentrates, ensuring compliance with Class II medical device regulations. Users can rely on this approval as evidence of regulatory scrutiny before clinical use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hemodialysis Concentrates - nipro-group.com, Nipro Dry Complete Dry Acid Concentrate for Hemodialysis (K193155 ..., Nipro Dry Complete Dry Acid Concentrate - Nipro Renal Solutions U | FDA ..., Nipro Dry Complete Dry Acid Concentrate for Hemodialysis

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Nipro Renal Solutions USA, Corporation
FDA Applicant
Nipro Renal Solutions USA, Corp.

Sources (1)

  • FDA 510(k) K193155 24 fields · synced Sep 19, 2026