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)
Feb 24, 2025CareFusion 303, Inc.
BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, ped
Open, Classified
FRNK211218
Feb 4, 2025Belmont Instrument LLC
Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids
Open, Classified
FRNK242735
Feb 4, 2025Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted rou
Open, Classified
FRNK183311
Jan 8, 2025Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Open, Classified
FRNK183311
Dec 27, 2024Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Open, Classified
FRNK230022
Dec 27, 2024Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
Open, Classified
FRNK133801
Nov 22, 2024Zyno Medical LLC
Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood prod
Open, Classified
FRNK100705
K130690
Nov 21, 2024Zyno Medical LLC
Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to
Open, Classified
FRNK100705
K130690
Nov 21, 2024ICU Medical, Inc.
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List
Open, Classified
FRNNone listed
Nov 8, 2024Baxter Healthcare Corporation
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Open, Classified
FRNK230041
Oct 31, 2024Smiths Medical ASD Inc.
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-020
Open, Classified
FRNK111275
Oct 9, 2024Zyno Medical LLC
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Open, Classified
FRNK100705
K130690
Sep 26, 2024Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Open, Classified
FRNK183311
Sep 13, 2024CareFusion 303, Inc.
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Open, Classified
FRNK211218
Sep 13, 2024CareFusion 303, Inc.
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Open, Classified
FRNK211218
Sep 13, 2024CareFusion 303, Inc.
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Open, Classified
FRNK211218
Sep 13, 2024CareFusion 303, Inc.
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Open, Classified
FRNK211218
Sep 13, 2024CareFusion 303, Inc.
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
Open, Classified
FRNK211218
Sep 7, 2024B Braun Medical Inc
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Open, Classified
FRNK191910
Aug 16, 2024Baxter Healthcare Corporation
Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)
Open, Classified
FRNK230041
Aug 16, 2024Baxter Healthcare Corporation
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spec
Open, Classified
FRNK230022
Aug 9, 2024ICU Medical Inc
Plum 360/A+ spare batteries. Item Number: SUB0000864.
Open, Classified
FRNK042081
K070398
Aug 9, 2024ICU Medical Inc
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS un
Open, Classified
FRNK042081
K070398
Aug 9, 2024ICU Medical Inc
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de
Open, Classified
FRNK141789
K161469
Aug 7, 2024Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Open, Classified
FRNK230022
Aug 3, 2024Smiths Medical ASD Inc.
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into
Open, Classified
FRNK111275
Jul 25, 2024B Braun Medical Inc
Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 1 each
Open, Classified
FRNK172831
K191910
Jul 25, 2024B Braun Medical Inc
Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump Kit, 1 each Component: N/A
Open, Classified
FRNK092313
Jul 25, 2024B Braun Medical Inc
Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor Space Syringe Pump, Infusion Pump, 1 each Component: N/A
Open, Classified
FRNK092313
K191910
Jul 25, 2024B Braun Medical Inc
Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Product Description: Perfusor Space Syringe Pump, Infusion Pump
Open, Classified
FRNK172831
K191910
Jul 25, 2024B Braun Medical Inc
Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each Component:
Open, Classified
FRNK092313
K172831 +1
Jul 3, 2024Zyno Medical LLC
Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
Open, Classified
FRNK130690
Jul 3, 2024CareFusion 303, Inc.
BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
Open, Classified
FRNK211218
May 21, 2024OptumHealth Care Solutions LLC
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
Open, Classified
FRNK153193
May 13, 2024Baxter Healthcare Corporation
Spectrum IQ Infusion pump, Product Code 357009
Open, Classified
FRNK230041
May 3, 2024Baxter Healthcare Corporation
Baxter Spectrum IQ Infusion Pump, Product Code 3570009
Open, Classified
FRNK230041
Apr 15, 2024Smiths Medical ASD Inc.
Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E
Open, Classified
FRNK040899
Apr 15, 2024Smiths Medical ASD Inc.
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 400
Open, Classified
FRNK111386
Apr 15, 2024Smiths Medical ASD Inc.
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3
Open, Classified
FRNK040899
Apr 11, 2024Fresenius Kabi USA, LLC
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Open, Classified
FRNK183311
Mar 28, 2024InfuTronix LLC
Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components
Open, Classified
FRNK140783
K153193
Mar 28, 2024InfuTronix LLC
Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
Open, Classified
FRNK140783
K153193
Mar 11, 2024Fresenius Kabi USA, LLC
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Completed
FRNK183311
Mar 11, 2024Fresenius Kabi USA, LLC
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Completed
FRNK183311
Feb 23, 2024Zyno Medical LLC
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or o
Open, Classified
FRNK130690
Feb 1, 2024Smiths Medical ASD Inc.
smiths medical Medfusion Model 4000 syringe pump
Open, Classified
FRNK111386
Feb 1, 2024Smiths Medical ASD Inc.
smiths medical Medfusion Model 3500 Syringe pump
Open, Classified
FRNK040899
Dec 20, 2023Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Open, Classified
FRNK183311
Nov 9, 2023Baxter Healthcare Corporation
Novum IQ Syringe infusion system, Product Code 40800BAXUS
Open, Classified
FRNK211125
Nov 7, 2023CareFusion 303, Inc.
Alaris PCA Module 8120
Open, Classified
FRNK051641
K072105 +2

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