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DK*300 Volumetric Infusion Controller

by Deka Research & Development Corp. 510(k)

Active United States

510(k) K843254

Overview

The DK*300 Volumetric Infusion Controller is an electronic infusion controller designed for intravascular use. It is classified as a Class II medical device under regulation number 880.5725 and is intended for general hospital settings.

The device received FDA 510(k) clearance (K843254) on October 11, 1984, and is substantially equivalent to a predicate device. It is manufactured by Deka Research & Development Corp. and is supplied as a non-sterile, reusable electronic controller for infusion therapy.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843254 Date11 Oct 1984ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LDR
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the DK*300 Volumetric Infusion Controller used for?

    The DK*300 Volumetric Infusion Controller is an electronic infusion controller designed for intravascular use, intended for general hospital settings to deliver fluids or medications with controlled flow rates during infusion therapy.

  • Is the DK*300 Volumetric Infusion Controller sterile or non-sterile, and is it single-use or reusable?

    The DK*300 Volumetric Infusion Controller is supplied as a non-sterile, reusable electronic controller, meaning it is not provided in a sterile condition and is intended for multiple uses after appropriate cleaning and disinfection between patients.

  • What regulatory pathway was used for the DK*300 Volumetric Infusion Controller, and when was it cleared?

    The DK*300 Volumetric Infusion Controller received FDA 510(k) clearance under submission K843254 on October 11, 1984, and was determined to be substantially equivalent to a predicate device, which is the regulatory route for moderate-risk Class II devices.