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)
Nov 7, 2023CareFusion 303, Inc.
BD Alaris Syringe Module, REF 8110
Open, Classified
FRNK051641
K072105 +2
Nov 7, 2023CareFusion 303, Inc.
BD Alaris PCU REF 8015
Open, Classified
FRNK051641
K072105 +2
Oct 25, 2023B. Braun Medical, Inc.
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
Open, Classified
FRNK142596
K191910
Oct 25, 2023B. Braun Medical, Inc.
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Open, Classified
FRNK142596
K191910
Oct 20, 2023EITAN MEDICAL LTD
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Open, Classified
FRNK192860
Oct 6, 2023Smiths Medical ASD Inc.
Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump
Open, Classified
FRNNone listed
Oct 6, 2023Smiths Medical ASD Inc.
Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump
Open, Classified
FRNNone listed
Oct 6, 2023Smiths Medical ASD Inc.
Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0105-78, i) 0105-249, j) 0106-00, k) 0106-01, l) 0106-23
Open, Classified
FRNK111386
Oct 6, 2023Smiths Medical ASD Inc.
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions: v3, v4, v5, and v6
Open, Classified
FRNK040899
Oct 6, 2023Smiths Medical ASD Inc.
Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
Open, Classified
FRNK040899
Oct 6, 2023Smiths Medical ASD Inc.
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
Open, Classified
FRNK040899
Sep 25, 2023Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled admin
Open, Classified
FRNK183311
Aug 18, 2023ICU Medical Inc
Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 300101013, 300101113, 30010
Open, Classified
FRNK141789
K161469
Jul 13, 2023Baxter Healthcare Corporation
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Open, Classified
FRNK230041
Jul 13, 2023Baxter Healthcare Corporation
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
Open, Classified
FRNK230022
Jun 6, 2023Avanos Medical, Inc.
ambIT Cassette Filter Male Luer, Product Code: 220266
Terminated
FRNK162165
Jun 6, 2023Avanos Medical, Inc.
SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
Terminated
FRNK162165
Jun 6, 2023Avanos Medical, Inc.
SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
Terminated
FRNK162165
Jun 6, 2023Avanos Medical, Inc.
AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
Terminated
FRNK162165
Jun 6, 2023Avanos Medical, Inc.
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Terminated
FRNK162165
May 16, 2023ICU Medical Inc
ASM Replacement Battery, Component Number SUB0000594
Open, Classified
FRNNone listed
May 16, 2023ICU Medical Inc
ASM Replacement Battery, Component Number SUB0000864
Open, Classified
FRNNone listed
May 16, 2023ICU Medical Inc
Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 1197
Open, Classified
FRNK042081
K070398
May 16, 2023ICU Medical Inc
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
Open, Classified
FRNK141789
K161469
Apr 18, 2023Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Open, Classified
FRNK183311
Mar 30, 2023Iradimed Corporation
Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
Open, Classified
FRNK050301
K090087 +1
Mar 1, 2023CareFusion 303, Inc.
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
Open, Classified
FRNK072105
Jan 6, 2023Bayer Medical Care, Inc.
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorode
Open, Classified
FRNK100798
Nov 21, 2022Smiths Medical ASD Inc.
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusi
Open, Classified
FRNK111386
Apr 18, 2022Smiths Medical ASD Inc.
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500S
Open, Classified
FRNK040899
Apr 18, 2022Smiths Medical ASD Inc.
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4
Open, Classified
FRNK111386
Feb 17, 2022Smiths Medical ASD Inc.
Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main
Open, Classified
FRNK040899
K111386
Jan 29, 2022Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
Open, Classified
FRNK133801
Jan 29, 2022Baxter Healthcare Corporation
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
Open, Classified
FRNK173084
Oct 19, 2021InfuTronix LLC
Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP
Open, Classified
FRNK153193
Oct 19, 2021Smiths Medical ASD Inc.
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 2
Terminated
FRNK111275
Aug 11, 2021Baxter Healthcare Corporation
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Terminated
FRNK173084
Aug 6, 2021BioMedical Equipment Service Co (BMES)
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
Terminated
FRNK133532
Aug 6, 2021Baxter Healthcare Corporation
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Terminated
FRNK173084
May 10, 2021STEP-HAR MEDICAL LLC
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Terminated
FRNK133532
Apr 2, 2021Tenacore LLC
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Terminated
FRNK133532
Apr 2, 2021Tenacore LLC
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
Terminated
FRNK133532
Mar 26, 2021Infusion Pump Repair
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Open, Classified
FRNK133532
Mar 25, 2021The Biomed Guys
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
Open, Classified
FRNK133532
Mar 24, 2021Pacific Medical Group Inc.
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
Open, Classified
FRNK133532
Mar 19, 2021Baxter Healthcare Corporation
Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
Terminated
FRNK173084
Mar 3, 2021CareFusion 303, Inc.
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
Open, Classified
FRNK133532
Jan 6, 2021Baxter Healthcare Corporation
Infusion Pump
Terminated
FRNK042121
K133801 +1
Nov 23, 2020Baxter Healthcare Corporation
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.
Open, Classified
FRNK173084
Nov 23, 2020Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.
Open, Classified
FRNK133801

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