Solution Set with 1.2 Micron Air Eliminating Filter

No FDA recalls on record, checked 24 Oct 2026.

510(k) Number

K161808 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

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 →