Atlas FDA

FRN

849 FDA 510(k) clearances · Product code

83 daysmedian time to decision
284 days90th percentile
849clearances measured

FDA profile

Official device name
Pump, Infusion
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 199,342 · 2022: 888,020 · 2023: 165,838 · 2024: 57,731 · 2025: 53,486 · 2026: 31,017
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
RemunityPRO+ Pump for Remodulin® (treprostinil) Injection (K253703)Deka R&D Corp2026-07-24
FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing (K252015)Koru Medical Systems, Inc.2026-01-28
SIGMA Spectrum Infusion Pump with Master Drug Library (K251640)Baxter Healthcare Corporation2025-07-28
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (K251636)Baxter Healthcare Corporation2025-07-28
MRidium 3870 MRI Infusion Pump System (3870) (K242752)Iradimed Corporation2025-05-28
BD Alaris Infusion System with Guardrails Suite MX (K243855)Carefusion 303, Inc.2025-04-25
Plum Solo™ Precision IV Pump (K242114)Icu Medical, Inc.2025-04-02
Plum Duo™ Precision IV Pump (K242115)Icu Medical, Inc.2025-04-02
RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (K250357)Deka Research & Development Corp.2025-03-11
Remunity 2.0 Pump for Remodulin (treprostinil) Injection (K241736)Deka Research and Development Corp.2025-01-16
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) (K242735)Belmont Medical Technologies2024-12-23
Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets (K242660)Zevex, Inc.2024-10-03
Novum IQ Syringe Pump (40800BAXUS) (K242390)Baxter Healthcare Corporation2024-09-05
Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets (K232793)Zevex, Inc.2024-05-17
Novum IQ Large Volume Pump (K211122)Baxter Healthcare Corporation2024-03-29
Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter (K231918)Koru Medical Systems2023-11-03
SAFIRA (K230083)Medovate Limited2023-10-31
Plum Duo™ Infusion System (K223607)Icu Medical, Inc.2023-08-24
BD Alaris System with Guardrails Suite MX v12.1.2 (K211218)Carefusion 303, Inc.2023-07-21
Spectrum IQ Infusion System with Dose IQ Safety Software (K230041)Baxter Healthcare Corporation2023-03-31
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (K230022)Baxter Healthcare Corporation2023-03-31
Avoset Infusion Pump System (K213744)Eitan Medical , Ltd.2023-03-10
Spectrum IQ Infusion System with Dose IQ Safety Software (K222048)Baxter Healthcare Corporation2022-09-06
Novum IQ Syringe Pump (K211125)Baxter Healthcare Corporation2022-08-30
FreedomEdge Syringe Infusion System (K214045)Repro-Medical System, Inc., Dba Koru Medical Systems2022-04-29
Spectrum IQ Infusion System with Dose IQ Safety Software (K220417)Baxter Healthcare Corporation2022-04-29
Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable (K210074)Fresenius Kabi AG2022-03-01
Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo (K210073)Fresenius Kabi AG2022-03-01
FREEDOM Integrated Syringe Infusion System (K200176)Repro-Med Systems, Inc. Dba Koru Medical Systems2021-12-15
FreedomEdge(R) Syringe Infusion System (K211206)Repro-Medical System, Inc., Dba Koru Medical Systems2021-11-09
Sapphire Infusion Pump, Sapphire administration sets (K192860)Q Core Medical , Ltd.2020-11-19
Ivenix Infusion System (IIS) (K183311)Ivenix, Inc.2019-06-07
Unity Subcutaneous Delivery System for Remodulin (K190182)DEKA Research & Development2019-05-06
Power Infuser (K172653)ZOLL Medical Corporation2018-07-18
Perfusor® Space Syringe Infusion Pump System (K172831)B.Braun Medical, Inc.2018-06-12
Spectrum IQ Infusion System, Dose IQ Safety Software (K173084)Baxter Healthcare Corporation2018-05-11
Integrated Catch-up Freedom Syringe Driver Infusion System (K162613)Repro-Med Systems, Inc. Dba Rms Medical Products2017-08-31
Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (K161469)Hospira, Inc.2017-03-28
Sapphire Infusion Pump (K161667)Q Core Medical , Ltd.2017-03-27
MRidium 3860+ MRI infusion Pump/ Monitoring System (K143369)Iradimed Corporation2016-12-15
Concert Medical Hands-Free Syringe (HFS) (K153599)Concert Medical, LLC2016-09-01
Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) (K153193)Zyno Medical, LLC2016-08-30
Navigator Aesthetic Delivery System (K151255)Carticept Medical, Inc.2015-12-30
Infusomat Space Volumetric Infusion Pump (K142596)B.Braun Medical, Inc.2015-06-18
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE (K141789)Hospira, Inc.2015-01-16
SAPPHIRE INFUSION PUMP (K141389)Q Core Medical , Ltd.2014-12-11
HALO AMBULATORY INFUSION SYSTEM (K140783)Zyno Medical, LLC2014-10-17
ALARIS SYSTEM WITH GUARDRAILS SUITE MX (K133532)Carefusion 303, Inc.2014-08-21
THE BELMONT RAPID INFUSER (K141654)Belmont Instrument Corporation2014-07-18
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE (K141102)Hospira, Inc.2014-07-08
BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY (K133801)Baxter Healthcare Corporation2014-05-07
SAPPHIRE INFUSION PUMP (K123049)Q Core Medical , Ltd.2013-10-17
KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET (K123822)Hk Surgical, Inc.2013-09-27
Z-800 INFUSION SYSTEM (K130690)Zyno Medical, LLC2013-06-12
AGILIA INFUSION SYSTEM (K121613)Fresenius Kabi AG2013-05-01
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) (K124053)Carticept Medical, Inc.2013-03-13
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE (K111275)Smiths Medical Asd, Inc.2013-02-01
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) (K122215)Carticept Medical, Inc.2012-10-26
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) (K120830)Carticept Medical, Inc.2012-04-16
ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION (K110535)Carefusion 303, Inc.2012-03-26
SYMBIQ INFUSION AND ADMINSTRATION SET (K110901)Hospira, Inc.2012-03-05
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) (K112067)Carticept Medical, Inc.2011-09-16
MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) (K111386)Smiths Medical MD, Inc.2011-08-29
NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 (K101194)Carticept Medical, Inc.2011-07-11
ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 (K100705)Zyno Medical, LLC2010-07-08
MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C (K100798)Medrad, Inc.2010-06-23
ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE (K100704)Disetronic Medical Systems AG2010-05-14
DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9) (K093332)Delphi Medical Systems2009-12-09
SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET (K091441)Synergetics, Inc.2009-10-30
MICROFUSE DUAL RATE INFUSER (K091386)Numia Medical Technology, LLC2009-10-02
ALARIS PC UNIT, MODELS 8000 AND 8015 (K091308)Cardinal Health 303,Inc.2009-07-09
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM (K083689)B.Braun Medical, Inc.2009-07-01
THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 (K091855)Belmont Instrument Corp.2009-07-01
POWER INFUSER, MODEL M100B-3A (K090736)ZOLL Medical Corporation2009-05-20
CRONO S-PID 50 (K091042)Cane S.R.L.2009-05-12
MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM (K090087)Iradimed Corporation2009-04-07
PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K081412)Hospira, Inc.2008-12-17
ABC SYRINGE INFUSION PUMP, MODEL 4100 (K072603)Elixir Corporation2008-10-23
GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE (K083019)Hospira, Inc.2008-10-22
AP 34 MULTI-THERAPY INFUSION PUMP (K082182)Q-Core, Ltd.2008-08-15
MEDRAD INTEGO PET INFUSION SYSTEM (K080297)Medrad, Inc.2008-06-17
MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY (K073051)Medrad, Inc.2008-05-30
T34L SYRINGE DRIVER (K080954)Caesarea Medical Electronics , Ltd.2008-05-16
LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP (K080743)Smiths Medical MD, Inc.2008-04-25
ALARIS SYSTEM WITH MMS, MODEL 8XXX (K072105)Cardinal Health 303,Inc.2007-12-28
DISPENSER DP 20 (K071588)NOUVAG AG2007-11-26
Z-800 VOLUMETRIC INFUSION PUMP (K071545)Zyno Medical, LLC2007-10-31
BODYGUARD PAIN MANAGER INFUSION SYSTEM (K070235)Caesarea Medical Electronics , Ltd.2007-05-18
AFF (MARK I) VOLUMETRIC INFUSION PUMP (K070529)Definitive Medical Technologies, Ltd.2007-05-08
HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 (K070398)Hospira, Inc.2007-04-24
COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION (K070125)Baxter Healthcare Corp2007-04-16
MODIFICATION TO: BODYGUARD INFUSION SYSTEM (K070718)Caesarea Medical Electronics , Ltd.2007-04-13
COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163 (K063696)Baxterhealthcare, Inc.2007-02-27
SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X (K070268)Cardinal Health 303,Inc.2007-02-23
STRYKER AUTO IRRIGATION SYSTEM (K061108)Stryker2007-02-02
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K (K052973)Baxter Healthcare Corp2007-01-25
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE (K062592)Smiths Medical MD, Inc.2006-11-29
SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X (K063288)Cardinal Health 303,Inc.2006-11-28
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM (K062699)B.Braun Medical, Inc.2006-10-26
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM (K062700)B.Braun Medical, Inc.2006-10-26
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