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

DateFirm and productCodeLinked 510(k)
Sep 11, 2026ICU Medical, Inc.
IV Sets with drip chambers
Open, Classified
FRNK141789
Aug 31, 2026Baxter Healthcare Corporation
Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
Open, Classified
FRNK242390
Aug 31, 2026Baxter Healthcare Corporation
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
Open, Classified
FRNK242390
Jul 10, 2026ICU Medical, Inc.
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
Open, Classified
FRNK242114
Jul 10, 2026ICU Medical, Inc.
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
Open, Classified
FRNK223607
Jun 5, 2026ICU Medical, Inc.
Plum Duo Precision IV Pump, 40002-0403
Open, Classified
FRNK242115
Jun 5, 2026ICU Medical, Inc.
Plum Duo Infusion Pump, 40002-0401
Open, Classified
FRNK223607
Jun 5, 2026ICU Medical, Inc.
Plum Solo Precision IV Pump, 40001-0401
Open, Classified
FRNK242114
Jun 3, 2026Fresenius Kabi USA, LLC
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Open, Classified
FRNK183311
May 29, 2026Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Open, Classified
FRNK183311
May 29, 2026Fresenius Kabi USA, LLC
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Open, Classified
FRNK183311
Mar 26, 2026CareFusion 303, Inc.
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Open, Classified
FRNK023264
K041241 +4
Feb 13, 2026Baxter Healthcare Corporation
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
Open, Classified
FRNK251636
Jan 29, 2026CareFusion 303, Inc.
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent admi
Open, Classified
FRNK211218
Jan 16, 2026Baxter Healthcare Corporation
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Open, Classified
FRNK251640
Jan 16, 2026ICU Medical, Inc.
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Open, Classified
FRNK242114
Jan 16, 2026ICU Medical, Inc.
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Open, Classified
FRNK242115
Jan 16, 2026ICU Medical, Inc.
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Open, Classified
FRNK223607
Jan 15, 2026ICU Medical, Inc.
Plum Duo Infusion System, List Number 40002-04-01
Open, Classified
FRNK223607
Jan 12, 2026Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Open, Classified
FRNK183311
Dec 16, 2025Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Open, Classified
FRNK183311
Dec 3, 2025Fresenius Kabi USA, LLC
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Open, Classified
FRNK183311
Dec 1, 2025Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Open, Classified
FRNK183311
Nov 20, 2025CareFusion 303, Inc.
BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infu
Open, Classified
FRNK211218
Oct 28, 2025Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Open, Classified
FRNK183311
Aug 29, 2025Baxter Healthcare Corporation
Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
Open, Classified
FRNNone listed
Aug 29, 2025Baxter Healthcare Corporation
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Open, Classified
FRNK242390
Aug 29, 2025Baxter Healthcare Corporation
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
Open, Classified
FRNK211122
Aug 22, 2025Baxter Healthcare Corporation
Spectrum IQ Infusion Pump, Product Code 3570009
Open, Classified
FRNK230041
Aug 14, 2025Baxter Healthcare Corporation
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Open, Classified
FRNK211122
Aug 6, 2025CareFusion 303, Inc.
BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Val
Open, Classified
FRNK022209
Aug 6, 2025ICU Medical, Inc.
Plum Duo Infusion System, List Number: 400020401
Open, Classified
FRNK223607
Aug 6, 2025CareFusion 303, Inc.
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Open, Classified
FRNK211218
Aug 1, 2025Fresenius Kabi USA, LLC
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
Open, Classified
FRNK183311
Aug 1, 2025Fresenius Kabi USA, LLC
LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
Open, Classified
FRNK183311
Aug 1, 2025Fresenius Kabi USA, LLC
LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
Open, Classified
FRNK183311
Aug 1, 2025Fresenius Kabi USA, LLC
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Open, Classified
FRNK183311
Jun 18, 2025ICU Medical, Inc.
ICU Medical Plum Solos, Item number 400011001; infusion pump
Open, Classified
FRNNone listed
Jun 18, 2025ICU Medical, Inc.
ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
Open, Classified
FRNK223607
Jun 12, 2025Baxter Healthcare Corporation
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Open, Classified
FRNK242390
Jun 6, 2025Zyno Medical LLC
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Open, Classified
FRNK100705
K130690
Jun 6, 2025Zyno Medical LLC
Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Open, Classified
FRNK100705
K130690
Jun 6, 2025Zyno Medical LLC
Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Open, Classified
FRNK100705
K130690
Jun 6, 2025Zyno Medical LLC
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Open, Classified
FRNK100705
K130690
May 20, 2025Baxter Healthcare Corporation
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Open, Classified
FRNK211122
May 7, 2025Smiths Medical ASD, Inc.
CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-
Open, Classified
FRNK111275
May 5, 2025Smiths Medical ASD, Inc.
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLI
Open, Classified
FRNK111275
Mar 21, 2025Baxter Healthcare Corporation
Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
Open, Classified
FRNK242390
Mar 6, 2025Baxter Healthcare Corporation
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Open, Classified
FRNK230041
Mar 6, 2025Baxter Healthcare Corporation
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
Open, Classified
FRNK133801

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