FRN — Pump, Infusion Class II

FDA Device Classification

Classification Details

Product Code
FRN
Device Class
Class II
Regulation Number
880.5725
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252015koru medical systemsFreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubinJanuary 28, 2026
K251636baxter healthcare corporationSpectrum IQ Infusion System with Dose IQ Safety Software (3570009)July 28, 2025
K251640baxter healthcare corporationSIGMA Spectrum Infusion Pump with Master Drug LibraryJuly 28, 2025
K242752iradimed corporationMRidium 3870 MRI Infusion Pump System (3870)May 28, 2025
K243855carefusion 303BD Alaris Infusion System with Guardrails Suite MXApril 25, 2025
K242115icu medicalPlum Duo™ Precision IV PumpApril 2, 2025
K242114icu medicalPlum Solo™ Precision IV PumpApril 2, 2025
K250357deka research and developmentRemunityPRO™ Pump for Remodulin® (treprostinil) InjectionMarch 11, 2025
K241736deka research and developmentRemunity 2.0 Pump for Remodulin (treprostinil) InjectionJanuary 16, 2025
K242735belmont medical technologiesBelmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid InfDecember 23, 2024
K242660zevexCurlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; CurliOctober 3, 2024
K242390baxter healthcare corporationNovum IQ Syringe Pump (40800BAXUS)September 5, 2024
K232793zevexCurlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; CurliMay 17, 2024
K211122baxter healthcare corporationNovum IQ Large Volume PumpMarch 29, 2024
K231918koru medical systemsFreedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate November 3, 2023
K230083medovate limitedSAFIRAOctober 31, 2023
K223607icu medicalPlum Duo™ Infusion SystemAugust 24, 2023
K211218carefusion 303BD Alaris System with Guardrails Suite MX v12.1.2July 21, 2023
K230041baxter healthcare corporationSpectrum IQ Infusion System with Dose IQ Safety SoftwareMarch 31, 2023
K230022baxter healthcare corporationBaxter SIGMA Spectrum Infusion Pump with Master Drug LibraryMarch 31, 2023