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Naturalyte Bicarbonate Concentrate-Dry Pack

by Erika, Inc. 510(k)

Active United States

510(k) K852310

Overview

The Naturalyte Bicarbonate Concentrate Dry Pack is a System, Dialysate Delivery, Central Multiple Patient device designed for hemodialysis. It provides a dry-form bicarbonate concentrate used to neutralize acid in dialysis fluid, maintaining electrolyte balance during renal replacement therapy. This formulation is intended for use in compatible three-stream hemodialysis machines to support metabolic acid-base regulation in patients with end-stage renal disease.

Supplied as a dry powder pack, the device is configured for single-use and requires reconstitution with water before use in hemodialysis systems. It is regulated under FDA 510(k) clearance (K852310) and falls under Regulation 876.5820, classified as a Class II medical device. Authorized for use in Gastroenterology and Urology settings, it is distributed as part of a multi-patient dialysis delivery system. Storage and handling must comply with sterile processing protocols for dialysis concentrates.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK852310 Date26 Jul 1985ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 5 Oct 2026.

Specification

510(k)

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

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Questions

  • What is the Naturalyte Bicarbonate Concentrate-Dry Pack used for?

    The Naturalyte Bicarbonate Concentrate-Dry Pack is designed for hemodialysis to neutralize acid in dialysis fluid, helping maintain electrolyte balance during renal replacement therapy. It is specifically formulated for patients with end-stage renal disease (ESRD) to support metabolic acid-base regulation.

  • How is the Naturalyte Bicarbonate Concentrate-Dry Pack supplied and prepared for use?

    The device is supplied as a dry powder pack intended for single-use only. Before use, it must be reconstituted with water according to the manufacturer’s instructions. The reconstituted solution is then used in compatible three-stream hemodialysis machines.

  • Is the Naturalyte Bicarbonate Concentrate-Dry Pack sterile?

    The device is intended to comply with sterile processing protocols for dialysis concentrates, though specific sterility assurances should be confirmed with the manufacturer’s handling and storage guidelines. Always follow sterile processing procedures to ensure patient safety.

  • Can the Naturalyte Bicarbonate Concentrate-Dry Pack be reused?

    No, the Naturalyte Bicarbonate Concentrate-Dry Pack is explicitly designed for single-use only. Reusing the pack could compromise sterility, efficacy, and patient safety, so it must not be reused after reconstitution.

  • What storage and handling requirements apply to the Naturalyte Bicarbonate Concentrate-Dry Pack?

    The device must be stored and handled according to sterile processing protocols for dialysis concentrates. This includes protecting it from moisture, contamination, and extreme temperatures. Always follow the manufacturer’s instructions for optimal storage conditions to maintain product integrity.