Infusor Small Volume Elastomeric Infusion Devices

• • Terminated Z-1609-2013 FDA Class II ·initiated 7 Jun 2013

  Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer.

• • Terminated Z-0588-2008 FDA Unclassified (pre-2012) ·initiated 29 Nov 2007

  Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling.

510(k) Number

K062457 ↗

FDA Product Code

MEB

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Solution Administration Sets with 0.2 Micron Filter Open recall

  Class II

  FDA 510(k) K153158 Active Cleared 28 Dec 2015

• Prismaflex System 8.10

  Class II

  FDA 510(k) K171671 Active Cleared 23 Feb 2018

• Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)

  Class II

  FDA 510(k) K251745 Active Cleared 16 Dec 2025

• Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) Open recall

  Class II

  FDA 510(k) K251636 Active Cleared 28 Jul 2025

• Novum IQ Large Volume Pump Open recall

  Class II

  FDA 510(k) K211122 Active Cleared 29 Mar 2024

• Altapore Shape

  Class II

  FDA 510(k) K200640 Active Cleared 8 May 2020

See all devices from Baxter Healthcare Corporation →