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Dialyte

by Renal Dynamics, Inc.

510(k) K823779

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK823779 Date17 Jan 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KPO
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Dialyte Dialysate Concentrate for Hemodialysis is a sterile, liquid or powder-based solution designed for hemodialysis procedures. It provides the essential electrolytes, glucose, and buffering agents required to maintain fluid and electrolyte balance during dialysis, facilitating the removal of waste products and excess fluids from the patient’s blood. This concentrate is formulated to comply with regulatory standards for hemodialysis solutions, ensuring compatibility with standard dialysis machines and patient safety.

Dialyte is supplied as either a liquid or powder concentrate, requiring dilution with water before use in hemodialysis systems. It is intended for single-use applications in clinical settings, including hospitals and dialysis centers, and must be prepared under aseptic conditions to maintain sterility. The product adheres to FDA regulatory requirements under classification 876.5820 and has been granted FDA 510(k) clearance as substantially equivalent to predicate devices. Storage and handling follow standard sterile medical device protocols to preserve efficacy and safety.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Dialyte Dialysate Concentrate used for?

    The Dialyte Dialysate Concentrate is designed specifically for hemodialysis procedures. It provides essential electrolytes, glucose, and buffering agents to maintain fluid and electrolyte balance in patients undergoing dialysis. This balance is critical for safely removing waste products and excess fluids from the bloodstream, supporting overall renal function during treatment.

  • How is the Dialyte Dialysate Concentrate supplied and prepared for use?

    Dialyte is supplied as either a sterile liquid or powder concentrate. Before use in hemodialysis systems, it must be diluted with water according to the manufacturer’s instructions. The dilution process ensures the correct concentration of electrolytes and other components for safe and effective hemodialysis. Always prepare the solution under aseptic conditions to maintain sterility.

  • Is the Dialyte Dialysate Concentrate intended for single-use or reuse?

    The Dialyte Dialysate Concentrate is intended for single-use only. After dilution and use in a hemodialysis procedure, any remaining solution should be discarded to prevent contamination and ensure patient safety. Single-use adherence is a key requirement for maintaining sterility and regulatory compliance in clinical settings.

  • What storage and handling guidelines should be followed for the Dialyte Dialysate Concentrate?

    Dialyte must be stored and handled according to standard sterile medical device protocols. This includes keeping the concentrate in its original, unopened packaging until ready for use, storing it in a clean, dry environment away from direct sunlight, and ensuring the storage temperature remains within the specified range (if applicable). Always follow the manufacturer’s instructions to preserve sterility and efficacy before and during preparation.

  • What regulatory approvals does the Dialyte Dialysate Concentrate hold?

    The Dialyte Dialysate Concentrate has been granted FDA 510(k) clearance, demonstrating it is substantially equivalent to predicate devices under classification 876.5820. This clearance ensures the product meets regulatory standards for safety and performance in hemodialysis applications. Always refer to the latest labeling for specific regulatory details.