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Dosi-Fuser

by Leventon, S.A.

510(k) K040752

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040752 Date7 Apr 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
MEB
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

The Dosi Fuser is an elastomeric infusion pump, a type of pump, infusion, elastomeric. It consists of an elastomeric balloon and an infusion line with a capillary device and a Luer-Lock connector. The device is used for continuous infusion.

The Dosi Fuser is supplied as a single-use device and is suitable for outpatient use. It is indicated for the administration of chemotherapy, analgesia, and antibiotic therapy. The device has an FDA 510(k) authorization and is classified under regulation number 880.5725.

Other devices from Leventon, S.A.

  • Tri-Ball

    Class II

  • Dosi-Flow, Models 20 & 30

    Class II

  • Spiro-Ball

    Class II

  • Dosi Flow

    Class II

Questions

AI-generated answers, 25 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 is the Dosi Fuser used for?

    The Dosi Fuser is used for the administration of chemotherapy, analgesia, and antibiotic therapy through continuous infusion.

  • Is the Dosi Fuser a single-use device?

    Yes, the Dosi Fuser is supplied as a single-use device, making it suitable for outpatient use without the need for reprocessing.

  • What type of connector does the Dosi Fuser have?

    The Dosi Fuser has a Luer-Lock connector, which provides a secure connection for the infusion line.