FDA Product Code
FDA Product Code FRN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5725
510(k) Clearances — 849 records · page 1 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) Injection | Deka R&D Corp | 2026-07-24 | Traditional | PDF ↗ |
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing | Koru Medical Systems, Inc. | 2026-01-28 | Traditional | PDF ↗ |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2025-07-28 | Traditional | PDF ↗ |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) | Baxter Healthcare Corporation | 2025-07-28 | Traditional | PDF ↗ |
| K242752 | MRidium 3870 MRI Infusion Pump System (3870) | Iradimed Corporation | 2025-05-28 | Traditional | PDF ↗ |
| K243855 | BD Alaris Infusion System with Guardrails Suite MX | Carefusion 303, Inc. | 2025-04-25 | Traditional | PDF ↗ |
| K242115 | Plum Duo Precision IV Pump | Icu Medical, Inc. | 2025-04-02 | Traditional | PDF ↗ |
| K242114 | Plum Solo Precision IV Pump | Icu Medical, Inc. | 2025-04-02 | Traditional | PDF ↗ |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. | 2025-03-11 | Special | PDF ↗ |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | Deka Research and Development Corp. | 2025-01-16 | Traditional | PDF ↗ |
| K242735 | Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) | Belmont Medical Technologies | 2024-12-23 | Traditional | PDF ↗ |
| K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets | Zevex, Inc. | 2024-10-03 | Special | PDF ↗ |
| K242390 | Novum IQ Syringe Pump (40800BAXUS) | Baxter Healthcare Corporation | 2024-09-05 | Special | PDF ↗ |
| K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets | Zevex, Inc. | 2024-05-17 | Traditional | PDF ↗ |
| K211122 | Novum IQ Large Volume Pump | Baxter Healthcare Corporation | 2024-03-29 | Traditional | PDF ↗ |
| K231918 | Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter | Koru Medical Systems | 2023-11-03 | Traditional | PDF ↗ |
| K230083 | SAFIRA | Medovate Limited | 2023-10-31 | Traditional | PDF ↗ |
| K223607 | Plum Duo Infusion System | Icu Medical, Inc. | 2023-08-24 | Traditional | PDF ↗ |
| K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 | Carefusion 303, Inc. | 2023-07-21 | Traditional | PDF ↗ |
| K230022 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2023-03-31 | Traditional | PDF ↗ |
| K230041 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | 2023-03-31 | Traditional | PDF ↗ |
| K213744 | Avoset Infusion Pump System | Eitan Medical , Ltd. | 2023-03-10 | Traditional | PDF ↗ |
| K222048 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | 2022-09-06 | Traditional | PDF ↗ |
| K211125 | Novum IQ Syringe Pump | Baxter Healthcare Corporation | 2022-08-30 | Traditional | PDF ↗ |
| K214045 | FreedomEdge Syringe Infusion System | Repro-Medical System, Inc., Dba Koru Medical Systems | 2022-04-29 | Traditional | PDF ↗ |
| K220417 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | 2022-04-29 | Traditional | PDF ↗ |
| K210074 | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable | Fresenius Kabi AG | 2022-03-01 | Traditional | PDF ↗ |
| K210073 | Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo | Fresenius Kabi AG | 2022-03-01 | Traditional | PDF ↗ |
| K200176 | FREEDOM Integrated Syringe Infusion System | Repro-Med Systems, Inc. Dba Koru Medical Systems | 2021-12-15 | Traditional | PDF ↗ |
| K211206 | FreedomEdge(R) Syringe Infusion System | Repro-Medical System, Inc., Dba Koru Medical Systems | 2021-11-09 | Traditional | PDF ↗ |
| K192860 | Sapphire Infusion Pump, Sapphire administration sets | Q Core Medical , Ltd. | 2020-11-19 | Traditional | PDF ↗ |
| K183311 | Ivenix Infusion System (IIS) | Ivenix, Inc. | 2019-06-07 | Traditional | PDF ↗ |
| K190182 | Unity Subcutaneous Delivery System for Remodulin | DEKA Research & Development | 2019-05-06 | Traditional | PDF ↗ |
| K172653 | Power Infuser | ZOLL Medical Corporation | 2018-07-18 | Traditional | PDF ↗ |
| K172831 | Perfusor® Space Syringe Infusion Pump System | B.Braun Medical, Inc. | 2018-06-12 | Traditional | PDF ↗ |
| K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software | Baxter Healthcare Corporation | 2018-05-11 | Traditional | PDF ↗ |
| K162613 | Integrated Catch-up Freedom Syringe Driver Infusion System | Repro-Med Systems, Inc. Dba Rms Medical Products | 2017-08-31 | Traditional | PDF ↗ |
| K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | Hospira, Inc. | 2017-03-28 | Traditional | PDF ↗ |
| K161667 | Sapphire Infusion Pump | Q Core Medical , Ltd. | 2017-03-27 | Traditional | PDF ↗ |
| K143369 | MRidium 3860+ MRI infusion Pump/ Monitoring System | Iradimed Corporation | 2016-12-15 | Traditional | PDF ↗ |
| K153599 | Concert Medical Hands-Free Syringe (HFS) | Concert Medical, LLC | 2016-09-01 | Traditional | PDF ↗ |
| K153193 | Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) | Zyno Medical, LLC | 2016-08-30 | Abbreviated | PDF ↗ |
| K151255 | Navigator Aesthetic Delivery System | Carticept Medical, Inc. | 2015-12-30 | Traditional | PDF ↗ |
| K142596 | Infusomat Space Volumetric Infusion Pump | B.Braun Medical, Inc. | 2015-06-18 | Traditional | PDF ↗ |
| K141789 | PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE | Hospira, Inc. | 2015-01-16 | Traditional | PDF ↗ |
| K141389 | SAPPHIRE INFUSION PUMP | Q Core Medical , Ltd. | 2014-12-11 | Traditional | PDF ↗ |
| K140783 | HALO AMBULATORY INFUSION SYSTEM | Zyno Medical, LLC | 2014-10-17 | Abbreviated | PDF ↗ |
| K133532 | ALARIS SYSTEM WITH GUARDRAILS SUITE MX | Carefusion 303, Inc. | 2014-08-21 | Traditional | PDF ↗ |
| K141654 | THE BELMONT RAPID INFUSER | Belmont Instrument Corporation | 2014-07-18 | Special | PDF ↗ |
| K141102 | HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE | Hospira, Inc. | 2014-07-08 | Special | PDF ↗ |
| K133801 | BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY | Baxter Healthcare Corporation | 2014-05-07 | Traditional | PDF ↗ |
| K123049 | SAPPHIRE INFUSION PUMP | Q Core Medical , Ltd. | 2013-10-17 | Traditional | PDF ↗ |
| K123822 | KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET | Hk Surgical, Inc. | 2013-09-27 | Traditional | PDF ↗ |
| K130690 | Z-800 INFUSION SYSTEM | Zyno Medical, LLC | 2013-06-12 | Special | PDF ↗ |
| K121613 | AGILIA INFUSION SYSTEM | Fresenius Kabi AG | 2013-05-01 | Traditional | PDF ↗ |
| K124053 | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) | Carticept Medical, Inc. | 2013-03-13 | Special | PDF ↗ |
| K111275 | CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE | Smiths Medical Asd, Inc. | 2013-02-01 | Traditional | PDF ↗ |
| K122215 | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) | Carticept Medical, Inc. | 2012-10-26 | Special | PDF ↗ |
| K120830 | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) | Carticept Medical, Inc. | 2012-04-16 | Special | PDF ↗ |
| K110535 | ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION | Carefusion 303, Inc. | 2012-03-26 | Traditional | PDF ↗ |
| K110901 | SYMBIQ INFUSION AND ADMINSTRATION SET | Hospira, Inc. | 2012-03-05 | Traditional | PDF ↗ |
| K112067 | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) | Carticept Medical, Inc. | 2011-09-16 | Traditional | PDF ↗ |
| K111386 | MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) | Smiths Medical MD, Inc. | 2011-08-29 | Traditional | PDF ↗ |
| K101194 | NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 | Carticept Medical, Inc. | 2011-07-11 | Traditional | PDF ↗ |
| K100705 | ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 | Zyno Medical, LLC | 2010-07-08 | Abbreviated | PDF ↗ |
| K100798 | MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C | Medrad, Inc. | 2010-06-23 | Traditional | PDF ↗ |
| K100704 | ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE | Disetronic Medical Systems AG | 2010-05-14 | Special | PDF ↗ |
| K093332 | DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9) | Delphi Medical Systems | 2009-12-09 | Traditional | PDF ↗ |
| K091441 | SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET | Synergetics, Inc. | 2009-10-30 | Traditional | PDF ↗ |
| K091386 | MICROFUSE DUAL RATE INFUSER | Numia Medical Technology, LLC | 2009-10-02 | Special | PDF ↗ |
| K091308 | ALARIS PC UNIT, MODELS 8000 AND 8015 | Cardinal Health 303,Inc. | 2009-07-09 | Traditional | PDF ↗ |
| K083689 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM | B.Braun Medical, Inc. | 2009-07-01 | Traditional | PDF ↗ |
| K091855 | THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 | Belmont Instrument Corp. | 2009-07-01 | Special | PDF ↗ |
| K090736 | POWER INFUSER, MODEL M100B-3A | ZOLL Medical Corporation | 2009-05-20 | Traditional | PDF ↗ |
| K091042 | CRONO S-PID 50 | Cane S.R.L. | 2009-05-12 | Special | PDF ↗ |
| K090087 | MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM | Iradimed Corporation | 2009-04-07 | Traditional | PDF ↗ |
| K081412 | PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | Hospira, Inc. | 2008-12-17 | Traditional | PDF ↗ |
| K072603 | ABC SYRINGE INFUSION PUMP, MODEL 4100 | Elixir Corporation | 2008-10-23 | Traditional | PDF ↗ |
| K083019 | GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE | Hospira, Inc. | 2008-10-22 | Traditional | PDF ↗ |
| K082182 | AP 34 MULTI-THERAPY INFUSION PUMP | Q-Core, Ltd. | 2008-08-15 | Traditional | PDF ↗ |
| K080297 | MEDRAD INTEGO PET INFUSION SYSTEM | Medrad, Inc. | 2008-06-17 | Traditional | PDF ↗ |
| K073051 | MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY | Medrad, Inc. | 2008-05-30 | Abbreviated | PDF ↗ |
| K080954 | T34L SYRINGE DRIVER | Caesarea Medical Electronics , Ltd. | 2008-05-16 | Special | PDF ↗ |
| K080743 | LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP | Smiths Medical MD, Inc. | 2008-04-25 | Traditional | PDF ↗ |
| K072105 | ALARIS SYSTEM WITH MMS, MODEL 8XXX | Cardinal Health 303,Inc. | 2007-12-28 | Special | PDF ↗ |
| K071588 | DISPENSER DP 20 | NOUVAG AG | 2007-11-26 | Traditional | PDF ↗ |
| K071545 | Z-800 VOLUMETRIC INFUSION PUMP | Zyno Medical, LLC | 2007-10-31 | Traditional | PDF ↗ |
| K070235 | BODYGUARD PAIN MANAGER INFUSION SYSTEM | Caesarea Medical Electronics , Ltd. | 2007-05-18 | Special | PDF ↗ |
| K070529 | AFF (MARK I) VOLUMETRIC INFUSION PUMP | Definitive Medical Technologies, Ltd. | 2007-05-08 | Traditional | PDF ↗ |
| K070398 | HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 | Hospira, Inc. | 2007-04-24 | Special | PDF ↗ |
| K070125 | COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION | Baxter Healthcare Corp | 2007-04-16 | Traditional | PDF ↗ |
| K070718 | MODIFICATION TO: BODYGUARD INFUSION SYSTEM | Caesarea Medical Electronics , Ltd. | 2007-04-13 | Special | PDF ↗ |
| K063696 | COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163 | Baxterhealthcare, Inc. | 2007-02-27 | Traditional | PDF ↗ |
| K070268 | SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X | Cardinal Health 303,Inc. | 2007-02-23 | Special | PDF ↗ |
| K061108 | STRYKER AUTO IRRIGATION SYSTEM | Stryker | 2007-02-02 | Traditional | PDF ↗ |
| K052973 | IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K | Baxter Healthcare Corp | 2007-01-25 | Traditional | PDF ↗ |
| K062592 | CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE | Smiths Medical MD, Inc. | 2006-11-29 | Traditional | PDF ↗ |
| K063288 | SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X | Cardinal Health 303,Inc. | 2006-11-28 | Special | PDF ↗ |
| K062700 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM | B.Braun Medical, Inc. | 2006-10-26 | Traditional | PDF ↗ |
| K062699 | PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM | B.Braun Medical, Inc. | 2006-10-26 | Traditional | PDF ↗ |
Product code FRN · Class II · General Hospital. Data: openFDA.