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Hemodialysis Concentrate Additives

by Dana Laboratories 510(k)

Active United States Open recall

510(k) K851431

Regulatory status

as of 29 Oct 2026

Recall ongoing. 7 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK851431 Date12 Jun 1985ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

8 recalls · 7 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-0991-2026 FDA Class II initiated 5 Nov 2025
    • Ongoing Z-0992-2026 FDA Class II initiated 5 Nov 2025
    • Ongoing Z-0989-2026 FDA Class II initiated 5 Nov 2025
    • Ongoing Z-0990-2026 FDA Class II initiated 5 Nov 2025
    • Ongoing Z-0987-2026 FDA Class II initiated 5 Nov 2025
    • Ongoing Z-0988-2026 FDA Class II initiated 5 Nov 2025

    Safety and efficacy of dialysis acid concentrate cannot be assured

    • Ongoing Z-0207-2025 FDA Class II initiated 27 Jul 2022

    Due to labeling issue. The box label is different that the gallon label in that gallon label shows a lower Calcium concentration than the box label.

    • Terminated Z-2402-2020 FDA Class II initiated 30 Apr 2020

    Incorrect labeling of dialysate concentration for hemodialysis.

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, 19 Sep 2026

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

This device is a Dialysate Concentrate for Hemodialysis (Liquid or Powder), classified under FDA regulation 876.5820. It is designed to be mixed with water to produce hemodialysis fluid, ensuring proper electrolyte balance, acid-base equilibrium, and overall fluid composition for patient treatment during dialysis procedures.

The Hemodialysis Concentrate Additives are supplied as a sterile, single-use liquid or powder formulation, intended for use in hemodialysis machines. They are regulated under FDA 510(k) clearance (K851431) and fall under device class II. Storage and handling must comply with sterile medical device protocols, and usage is restricted to authorized clinical settings where hemodialysis is performed.

Other devices from Dana Laboratories

Questions

AI-generated answers, 19 Sep 2026

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

  • What types of hemodialysis concentrate additives does Dana Laboratories offer, and how are they supplied?

    Dana Laboratories offers hemodialysis concentrate additives in both sterile liquid and sterile powder formulations. Both are designed as single-use products to be mixed with water in hemodialysis machines, ensuring proper electrolyte balance and fluid composition for patient treatment. The sterile packaging ensures safety for clinical use.

  • Are these additives reusable, or are they intended for one-time use only?

    These hemodialysis concentrate additives are strictly single-use products. They are supplied in sterile packaging to prevent contamination and ensure patient safety, making reuse unsafe and prohibited. Each batch is intended for a single hemodialysis procedure.

  • How should these hemodialysis concentrate additives be stored, and what precautions should be taken?

    Since these are sterile medical devices, they must be stored according to sterile medical device protocols. This includes keeping them in a clean, dry environment, protected from moisture, extreme temperatures, and direct sunlight. Always follow manufacturer instructions to maintain sterility until use.

  • What regulatory pathway was followed for FDA clearance of these hemodialysis concentrate additives?

    These additives were cleared through the FDA 510(k) pathway under clearance number K851431, classified as Class II devices. The submission was reviewed by the Gastroenterology and Urology (GU) Advisory Committee in 1985, with a decision of Substantially Equivalent (SESE) to a predicate device. The regulatory classification (KPO) reflects their use in hemodialysis.