Medical Device Manufacturer · US , Walker , MI

Icu Medical, Inc.

63 submissions · 62 cleared · Since 1984
63
Total
62
Cleared
0
Denied

Icu Medical, Inc. — FDA 510(k) Submissions

Icu Medical, Inc. has submitted 63 FDA 510(k) premarket notifications since 1984, of which 62 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Set, Administration, Intravascular, Stopcock, I.v. Set, Pump, Infusion, Needle, Hypodermic, Single Lumen, Syringe, Piston . Use the specialty filter in the sidebar to narrow results.

63 devices
1–25 of 63
Clave? Neutral-Displacement Needlefree Connectors
K250616 · FPA Set, Administration,... · General Hospital
Jun 2025 97d
Plum Solo? Precision IV Pump
K242114 · FRN Pump, Infusion · General Hospital
Apr 2025 257d
Plum Duo? Precision IV Pump
K242115 · FRN Pump, Infusion · General Hospital
Apr 2025 257d
LifeShield Infusion Safety Software Suite
K242117 · PHC Infusion Safety... · General Hospital
Apr 2025 257d
Rio? Drug Reconstitution Transfer Device
K243985 · LHI Set, I.v. Fluid Transfer · General Hospital
Jan 2025 30d
LifeShield? Infusion Safety Software Suite
K223606 · PHC Infusion Safety... · General Hospital
Aug 2023 265d
Plum Duo? Infusion System
K223607 · FRN Pump, Infusion · General Hospital
Aug 2023 265d
ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
K173477 · ONB Closed Antineoplastic And... · General Hospital
Aug 2018 291d
Diana Medication Transfer Set
K170110 · ONB Closed Antineoplastic And... · General Hospital
Aug 2018 575d
Cogent Hemodynamic Monitoring System
K152006 · DXQ Blood Pressure Cuff · Cardiovascular
May 2016 289d
Hospira Extension Sets
K151969 · FPA Set, Administration,... · General Hospital
Jan 2016 187d
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER
K140129 · DQE Catheter, Oximeter,... · Cardiovascular
Jul 2014 167d
CHEMOLOCK, CHEMOLOCK PORT
K131549 · ONB Closed Antineoplastic And... · General Hospital
Jul 2013 58d
HIGH PRESSURE SETS-400 PSI
K100576 · FPA Set, Administration,... · General Hospital
Dec 2010 291d
CLAVE NEUTRON
K100434 · FPA Set, Administration,... · General Hospital
Jul 2010 143d
ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE
K090189 · FPA Set, Administration,... · General Hospital
Apr 2009 74d
SPINNING SPIROS, MODEL CH-2000
K082806 · FPA Set, Administration,... · General Hospital
Apr 2009 194d
ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
K082836 · FMG Stopcock, I.v. Set · General Hospital
Feb 2009 152d
CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX
K081361 · FPA Set, Administration,... · General Hospital
Aug 2008 105d
GRADUATED ADAPTER WITH CLAVE
K080007 · EZD Catheter, Straight · Gastroenterology & Urology
May 2008 132d
UNIVERSAL VIAL ACCESS SPIKE
K080989 · FMF Syringe, Piston · General Hospital
May 2008 25d
CLAVE STOPCOCK
K080077 · FMG Stopcock, I.v. Set · General Hospital
Feb 2008 33d
ICU MEDICAL SINGLE-USE SYRINGE
K070856 · FMF Syringe, Piston · General Hospital
Oct 2007 191d
PULL TAB SQUEEZE FLUSH
K070979 · KRA Catheter, Continuous Flush · Cardiovascular
Sep 2007 166d
GENIE, MODEL CH-200
K070633 · FMF Syringe, Piston · General Hospital
Jun 2007 90d
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