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Aff (Mark I) Volumetric Infusion Pump

by Definitive Medical Technologies, Ltd. 510(k)

Active United States

510(k) K070529

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK070529 Date8 May 2007ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

5 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2220-2016 FDA Class II initiated 14 Jun 2016
    • Terminated Z-2219-2016 FDA Class II initiated 14 Jun 2016

    WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model 300000) and Unapproved Changes to the Intended Use of the Triton FP Infusion Pump (model 400000).

    • Terminated Z-0242-2016 FDA Class II initiated 1 Oct 2015

    The device might fail to detect air in line while infusing the medication Venofer. This may occur when a drop of Venofer gets stuck in the tubing adjacent to the bubble detector and the Total Volume Limit is programmed higher than the actual bag volume.

    • Terminated Z-1122-2014 FDA Class II initiated 17 Feb 2014

    WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due to the label on the right side of the pump containing an incorrect instruction.

    • Terminated Z-0307-2011 FDA Unclassified (pre-2012) initiated 17 Jun 2010

    Pump door may be in a near shut position, but unlatched, and the "Door Open" alarm may not sound.

Specification

510(k)

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