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Dosi Flow

by Leventon, S.A.

510(k) K851058

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK851058 Date29 Apr 1985ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2601-2011 FDA Unclassified (pre-2012) initiated 11 Mar 2011

    Leventon, S.A.U. Barcelona, Spain is recalling DOSI-FLOW REGULATOR, Part Number 259-0250, Lot Numbers 101444L and 101494L. Product has potential to leak.

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  • Withdrawn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
LDR
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
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.

The Dosi Flow is an infusion controller, electronic, intravascular, designed to regulate and deliver intravenous fluids at precise flow rates and durations. It operates as a standalone device to ensure accurate dosing for therapeutic infusions, supporting controlled administration in clinical settings.

Supplied as a reusable electronic device, the Dosi Flow is intended for use in general hospital environments and adheres to FDA 510(k) clearance (K851058) under product code LDR. It requires proper calibration and maintenance per manufacturer guidelines, with no specified sterility or MRI compatibility in the regulatory data. Sizes are differentiated by model numbers (e.g., 1, 2, 3, 10, 20, 30), though exact dimensions or compatibility details are not provided.

Other devices from Leventon, S.A.

  • Tri-Ball

    Class II

  • Dosi-Flow, Models 20 & 30

    Class II

  • Spiro-Ball

    Class II

  • Dosi-Fuser

    Class II