ClearanceBrief
Panels › General Hospital › Product code FRN · Class 2

Pump, Infusion

Regulation 880.5725

2510(k)s in 12 months (849 all time)
24recalls in 12 months (724 all time)
672recalls that name a 510(k)
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Top companies in FRN

Company510(k)sRecalls
Baxter Healthcare Corp51128
Hospira, Inc.12129
Stryker Instruments Div. of Stryker Corporation078
Abbott Laboratories674
Carefusion 303, Inc.461
Icu Medical, Inc.443
Smiths Medical Asd, Inc.142
B.Braun Medical, Inc.1122
Y260
Zevex International, Inc.025
Decided510(k)Device and applicantCode
Jul 24, 2026K253703RemunityPRO+ Pump for Remodulin® (treprostinil) Injection
Deka R&D Corp
FRN
Jan 28, 2026K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
Koru Medical Systems, Inc.
FRN
Jul 28, 2025K251640SIGMA Spectrum Infusion Pump with Master Drug Library
Baxter Healthcare Corporation
FRN
Jul 28, 2025K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
Baxter Healthcare Corporation
FRN
May 28, 2025K242752MRidium 3870 MRI Infusion Pump System (3870)
Iradimed Corporation
FRN
Apr 25, 2025K243855BD Alaris Infusion System with Guardrails Suite MX
Carefusion 303, Inc.
FRN
Apr 2, 2025K242115Plum Duo™ Precision IV Pump
Icu Medical, Inc.
FRN
Apr 2, 2025K242114Plum Solo™ Precision IV Pump
Icu Medical, Inc.
FRN
Mar 11, 2025K250357RemunityPRO™ Pump for Remodulin® (treprostinil) Injection
Deka Research & Development Corp.
FRN
Jan 16, 2025K241736Remunity 2.0 Pump for Remodulin (treprostinil) Injection
Deka Research and Development Corp.
FRN
Dec 23, 2024K242735Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/m
Belmont Medical Technologies
FRN
Oct 3, 2024K242660Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets
Zevex, Inc.
FRN
Sep 5, 2024K242390Novum IQ Syringe Pump (40800BAXUS)
Baxter Healthcare Corporation
FRN
May 17, 2024K232793Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
Zevex, Inc.
FRN
Mar 29, 2024K211122Novum IQ Large Volume Pump
Baxter Healthcare Corporation
FRN
Nov 3, 2023K231918Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Ne
Koru Medical Systems
FRN
Oct 31, 2023K230083SAFIRA
Medovate Limited, GB
FRN
Aug 24, 2023K223607Plum Duo™ Infusion System
Icu Medical, Inc.
FRN
Jul 21, 2023K211218BD Alaris System with Guardrails Suite MX v12.1.2
Carefusion 303, Inc.
FRN
Mar 31, 2023K230041Spectrum IQ Infusion System with Dose IQ Safety Software
Baxter Healthcare Corporation
FRN
Mar 31, 2023K230022Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
Baxter Healthcare Corporation
FRN
Mar 10, 2023K213744Avoset Infusion Pump System
Eitan Medical , Ltd., IL
FRN
Sep 6, 2022K222048Spectrum IQ Infusion System with Dose IQ Safety Software
Baxter Healthcare Corporation
FRN
Aug 30, 2022K211125Novum IQ Syringe Pump
Baxter Healthcare Corporation
FRN
Apr 29, 2022K220417Spectrum IQ Infusion System with Dose IQ Safety Software
Baxter Healthcare Corporation
FRN
Apr 29, 2022K214045FreedomEdge Syringe Infusion System
Repro-Medical System, Inc., Dba Koru Medical Systems
FRN
Mar 1, 2022K210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable
Fresenius Kabi AG, DE
FRN
Mar 1, 2022K210073Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
Fresenius Kabi AG, DE
FRN
Dec 15, 2021K200176FREEDOM Integrated Syringe Infusion System
Repro-Med Systems, Inc. Dba Koru Medical Systems
FRN
Nov 9, 2021K211206FreedomEdge(R) Syringe Infusion System
Repro-Medical System, Inc., Dba Koru Medical Systems
FRN
Nov 19, 2020K192860Sapphire Infusion Pump, Sapphire administration sets
Q Core Medical , Ltd., IL
FRN
Jun 7, 2019K183311Ivenix Infusion System (IIS)
Ivenix, Inc.
FRN
May 6, 2019K190182Unity Subcutaneous Delivery System for Remodulin
DEKA Research & Development
FRN
Jul 18, 2018K172653Power Infuser
ZOLL Medical Corporation
FRN
Jun 12, 2018K172831Perfusor® Space Syringe Infusion Pump System
B.Braun Medical, Inc.
FRN
May 11, 2018K173084Spectrum IQ Infusion System, Dose IQ Safety Software
Baxter Healthcare Corporation
FRN
Aug 31, 2017K162613Integrated Catch-up Freedom Syringe Driver Infusion System
Repro-Med Systems, Inc. Dba Rms Medical Products
FRN
Mar 28, 2017K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module
Hospira, Inc.
FRN
Mar 27, 2017K161667Sapphire Infusion Pump
Q Core Medical , Ltd., IL
FRN
Dec 15, 2016K143369MRidium 3860+ MRI infusion Pump/ Monitoring System
Iradimed Corporation
FRN
Sep 1, 2016K153599Concert Medical Hands-Free Syringe (HFS)
Concert Medical, LLC
FRN
Aug 30, 2016K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion
Zyno Medical, LLC
FRN
Dec 30, 2015K151255Navigator Aesthetic Delivery System
Carticept Medical, Inc.
FRN
Jun 18, 2015K142596Infusomat Space Volumetric Infusion Pump
B.Braun Medical, Inc.
FRN
Jan 16, 2015K141789PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE
Hospira, Inc.
FRN
Dec 11, 2014K141389SAPPHIRE INFUSION PUMP
Q Core Medical , Ltd.
FRN
Oct 17, 2014K140783HALO AMBULATORY INFUSION SYSTEM
Zyno Medical, LLC
FRN
Aug 21, 2014K133532ALARIS SYSTEM WITH GUARDRAILS SUITE MX
Carefusion 303, Inc.
FRN
Jul 18, 2014K141654THE BELMONT RAPID INFUSER
Belmont Instrument Corporation
FRN
Jul 8, 2014K141102HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
Hospira, Inc.
FRN

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