ClearanceBrief
510(k) K040899 ยท FRN Pump, Infusion

MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP

ApplicantMedex, Inc., Dublin OH, US
DecisionSubstantially Equivalent, Apr 30, 2004
ReceivedApr 6, 2004
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K040899

DateFirm and productCodeLinked 510(k)
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
FRNNone listed
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
FRNNone listed
Feb 1, 2024Smiths Medical ASD Inc.
smiths medical Medfusion Model 3500 Syringe pump
Open, Classified
FRNNone listed
Oct 6, 2023Smiths Medical ASD Inc.
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
Open, Classified
FRNNone listed
Oct 6, 2023Smiths Medical ASD Inc.
Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
Open, Classified
FRNNone listed
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
FRNNone listed
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
FRNNone listed
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
FRNNone listed
Aug 6, 2020Smiths Medical ASD Inc.
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Open, Classified
FRNNone listed
Aug 6, 2020Smiths Medical ASD Inc.
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
Open, Classified
FRNNone listed
Apr 13, 2018Smiths Medical ASD Inc.
Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Terminated
FRNNone listed
Mar 5, 2018Smiths Medical ASD Inc.
Medfusion Syringe Pump 3500 Series The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood
Terminated
FRNNone listed
Mar 5, 2018Smiths Medical ASD Inc.
Medfusion Syringe Pump 3010 Series The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood
Terminated
FRNNone listed
Aug 22, 2017Smiths Medical ASD Inc.
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of
Terminated
FRNNone listed
Mar 26, 2013Smiths Medical ASD, Inc.
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
Terminated
FRNNone listed
Mar 14, 2012Smiths Medical ASD, Inc.
Smiths Medical, Medfusion 3500 Syringe Pumps, Software version 5.0.0, Rx Only. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood o
Terminated
FRNNone listed
Aug 2, 2010Smiths Medical ASD, Inc.
MEDFUSION SYRINGE INFUSION PUMP, MODELS 3010 AND 3010a WITH SOFTWARE VERSIONS 2.0.2, 2.0.3, AND 2.0.4 Medfusion Syringe Infusion Pumps are designed for use in critical care areas for the administrati
Terminated
FRNNone listed
Jan 15, 2010Smiths Medical ASD, Inc.
Smiths Medical Medfusion model 3500 syringe Infusion pump, software version V3.0.6. Model 3500. Rx Only. Smiths Medical MD, Inc., St. Paul, Minnesota 55112 (USA).
Terminated
FRNNone listed
Jan 15, 2010Smiths Medical ASD, Inc.
Smiths Medical Medfusion model 3010a syringe Infusion pump. REF 3010A. Rx Only. Smiths Medical MD, Inc., St. Paul, Minnesota 55112 (USA)
Terminated
FRNNone listed
Mar 9, 2009Smiths Medical MD, Inc.
Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V3.0.6. A small, lightweight and portable syringe infusion pump. The Medfusion 3500 syringe pump is indicated for use w
Terminated
FRNNone listed
Mar 9, 2009Smiths Medical MD, Inc.
Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V4.1.5. A small, lightweight and portable syringe infusion pump. The Medfusion 3500 syringe pump is indicated for use w
Terminated
FRNNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.