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Volumetric Infusion Controller

by Deka Research and Development 510(k)

Active United States

510(k) K153760

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK153760 Date3 Oct 2016ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
FDA applicant
DEKA Research & Development
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
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 Volumetric Infusion Controller DK*300 is an Intravascular Electronic Infusion Controller (Device Class II), designed to regulate the delivery of intravenous fluids under gravity. It is intended for administering general maintenance fluids and non-critical antibiotics to adult patients in a clinical setting. The device operates via volumetric control to ensure precise fluid administration without the need for electrical power sources or battery operation. Its design excludes the delivery of critical fluids or high-risk medications.

The device is supplied as a reusable medical instrument, intended for use in general hospital settings by trained medical professionals. It is not classified as sterile and requires proper cleaning and maintenance between uses. The Volumetric Infusion Controller DK*300 adheres to FDA 510(k) clearance (K153760) under regulatory classification LDR (Low Risk Device) and falls under regulation 880.5725. No MRI safety information or specific storage conditions are indicated in the regulatory data.

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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 Volumetric Infusion Controller DK*300 used for?

    The DK*300 is designed to regulate the delivery of intravenous fluids under gravity, specifically for administering general maintenance fluids and non-critical antibiotics to adult patients in clinical settings. Its volumetric control ensures accurate fluid administration without relying on electrical power or batteries. It is not intended for critical fluids or high-risk medications.

  • Is the Volumetric Infusion Controller DK*300 single-use or reusable?

    The DK*300 is supplied as a reusable medical instrument. Since it is not classified as sterile, it requires thorough cleaning and maintenance between uses by trained medical professionals in hospital settings.

  • Does the DK*300 require any special storage conditions?

    The regulatory data does not specify any special storage conditions for the DK*300. However, as a reusable device, it should be stored in a clean, dry environment to maintain functionality and hygiene between uses.

  • What regulatory approval does the DK*300 hold?

    The DK*300 holds FDA 510(k) clearance under the classification of Low Risk Device (LDR) with the clearance number K153760. It is intended for use in general hospital settings and adheres to regulation 880.5725.

  • Can the DK*300 be used with MRI equipment?

    The regulatory data does not provide any information regarding MRI safety for the DK*300. Clinicians should verify compatibility with their specific MRI protocols before use.