Company · US

ICU Medical, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2026. Name variants (Inc, Corp, punctuation) are merged.

72510(k) clearances (4 in 12 months)

656recalls (25 in 12 months)

583recalls that name a 510(k)

Product codes

Code	Device	Records
FPA	Set, Administration, Intravascular	214
DRS	Transducer, Blood-Pressure, Extravascular	198
FMG	Stopcock, I.V. Set	111
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	72
FRN	Pump, Infusion	47
N/A		10
DQE	Catheter, Oximeter, Fiber-Optic	8
MRZ	Accessories, Pump, Infusion	7
DQO	Catheter, Intravascular, Diagnostic	6
NEP	System/Device, Pharmacy Compounding	6
PHC	Infusion Safety Management Software	6
FMF	Syringe, Piston	5
FMI	Needle, Hypodermic, Single Lumen	4
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	3
DXQ	Blood Pressure Cuff	3
GAX	Tourniquet, Nonpneumatic	3
KRB	Probe, Thermodilution	3
LHI	Set, I.V. Fluid Transfer	3
QBP	Cap, Device Disinfectant	3
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	2

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Sep 18, 2026	K262532	NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) ICU Medical	LGZ
Apr 2, 2026	K252130	LifeShield Infusion Safety Software Suite Icu Medical, Inc.	PHC
Mar 27, 2026	K252006	OTTO Disinfecting Cap Icu Medical, Inc.	QBP
Mar 20, 2026	K251980	ClaveQS Bag Icu Medical, Inc.	KPE
Jun 5, 2025	K250616	Clave Neutral-Displacement Needlefree Connectors Icu Medical, Inc.	FPA
Apr 2, 2025	K242117	LifeShield Infusion Safety Software Suite Icu Medical, Inc.	PHC
Apr 2, 2025	K242115	Plum Duo Precision IV Pump Icu Medical, Inc.	FRN
Apr 2, 2025	K242114	Plum Solo Precision IV Pump Icu Medical, Inc.	FRN
Jan 22, 2025	K243985	Rio Drug Reconstitution Transfer Device Icu Medical, Inc.	LHI
Dec 20, 2023	K232048	Cogent Hemodynamic Monitoring System; Cogent HMS Icu Medical	DXG
Aug 24, 2023	K223607	Plum Duo Infusion System Icu Medical, Inc.	FRN
Aug 24, 2023	K223606	LifeShield Infusion Safety Software Suite Icu Medical, Inc.	PHC
Apr 20, 2020	K192154	Rio Vial-to-Bag Drug Reconstitution Device Icu Medical	LHI
Mar 6, 2020	K190918	SwabTip Male Disinfectant Cap Icu Medical	QBP
Oct 23, 2019	K190157	Diana ChemoClave Transfer Set Icu Medical	ONB
Aug 31, 2018	K173477	ChemoCLAVE Cytotoxic Medication Preparation and Delivery System Icu Medical, Inc.	ONB
Aug 10, 2018	K170110	Diana Medication Transfer Set Icu Medical, Inc.	ONB
Aug 25, 2017	K171346	Sapphire Sets Icu Medical	MRZ
May 5, 2016	K152006	Cogent Hemodynamic Monitoring System Icu Medical, Inc.	DXQ
Jan 19, 2016	K151969	Hospira Extension Sets Icu Medical, Inc.	FPA
Jul 2, 2014	K140129	PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER Icu Medical, Inc.	DQE
Jul 26, 2013	K131549	CHEMOLOCK, CHEMOLOCK PORT Icu Medical, Inc.	ONB
Dec 17, 2010	K100576	HIGH PRESSURE SETS-400 PSI Icu Medical, Inc.	FPA
Jul 9, 2010	K100434	CLAVE NEUTRON Icu Medical, Inc.	FPA
Apr 10, 2009	K090189	ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE Icu Medical, Inc.	FPA
Apr 6, 2009	K082806	SPINNING SPIROS, MODEL CH-2000 Icu Medical, Inc.	FPA
Feb 25, 2009	K082836	ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES Icu Medical, Inc.	FMG
Aug 28, 2008	K081361	CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX Icu Medical, Inc.	FPA
May 13, 2008	K080007	GRADUATED ADAPTER WITH CLAVE Icu Medical, Inc.	EZD
May 2, 2008	K080989	UNIVERSAL VIAL ACCESS SPIKE Icu Medical, Inc.	FMF
Feb 13, 2008	K080077	CLAVE STOPCOCK Icu Medical, Inc.	FMG
Oct 5, 2007	K070856	ICU MEDICAL SINGLE-USE SYRINGE Icu Medical, Inc.	FMF
Sep 19, 2007	K070979	PULL TAB SQUEEZE FLUSH Icu Medical, Inc.	KRA
Jun 5, 2007	K070633	GENIE, MODEL CH-200 Icu Medical, Inc.	FMF
Apr 16, 2007	K063784	DYE MANAGEMENT SYSTEM Icu Medical, Inc.	DQO
Mar 20, 2007	K070532	SPIROS Icu Medical, Inc.	FPA
Feb 10, 2006	K052594	WILLCARE, MODEL GW-1020 Icu Medical, Inc.	FRN
Jan 10, 2006	K053106	TEGO, MODEL D1000 Icu Medical, Inc.	FPA
Dec 22, 2005	K052865	HOSPIRA CATH LAB CONVENIENCE KITS Icu Medical, Inc.	DQO
Aug 3, 2005	K051437	CML 1000 Icu Medical, Inc.	FPA
Sep 1, 2004	K042182	Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 Icu Medical, Inc.	FPA
Aug 11, 2004	K040710	TEGO NEEDLE FREE ACCESS ACCESS DEVICE Icu Medical, Inc.	FPA
Jul 28, 2004	K041410	PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118 Icu Medical, Inc.	FPA
Apr 12, 2004	K033290	TALON INFUSION SET, MODEL IP XXXX Icu Medical, Inc.	FPA
Dec 4, 2003	K021692	CLC2000 CATHETER PATENCY DEVICE Icu Medical, Inc.	FPA
Jan 11, 2001	K003513	TAXOL ADMINISTRATION SET Icu Medical, Inc.	FPA
May 10, 2000	K000472	POSI-LINK Icu Medical, Inc.	FPA
Dec 24, 1998	K983559	BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR Icu Medical, Inc.	FJK
Jan 9, 1998	K974589	SMARTVALVE Icu Medical, Inc.	FPA
Nov 17, 1997	K973167	POSITIVE PRESSURE CONNECTOR Icu Medical, Inc.	FPA

Newest 50 of 72.

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Sep 17, 2026	ICU Medical, Inc. CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-2 Open, Classified	LHI	K162219
Sep 11, 2026	ICU Medical, Inc. IV Sets with drip chambers Open, Classified	FMG	K964435
Sep 11, 2026	ICU Medical, Inc. IV Sets with drip chambers Open, Classified	FRN	K141789
Sep 11, 2026	ICU Medical, Inc. IV Sets with drip chambers Open, Classified	ONB	K131549 K170110 +1
Sep 11, 2026	ICU Medical, Inc. IV Sets with drip chambers Open, Classified	FPA	K081361 K100576 +3
Sep 11, 2026	ICU Medical, Inc. Oncology sets with drip chambers Open, Classified	ONB	K131549 K173477
Sep 11, 2026	ICU Medical, Inc. Oncology sets with drip chambers Open, Classified	FPA	K081361
Sep 11, 2026	ICU Medical, Inc. IV Non-Dedicated Gravity Administration Sets with drip chambers Open, Classified	FMG	K964435
Sep 11, 2026	ICU Medical, Inc. Plum administration sets Open, Classified	FPA	None listed
Jul 17, 2026	ICU Medical Inc. Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow Open, Classified	LGZ	K911383
Jul 10, 2026	ICU Medical, Inc. ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump Open, Classified	FRN	K242114
Jul 10, 2026	ICU Medical, Inc. ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump Open, Classified	FRN	K223607
Jun 5, 2026	ICU Medical, Inc. Plum Duo Precision IV Pump, 40002-0403 Open, Classified	FRN	K242115
Jun 5, 2026	ICU Medical, Inc. Plum Duo Infusion Pump, 40002-0401 Open, Classified	FRN	K223607
Jun 5, 2026	ICU Medical, Inc. Plum Solo Precision IV Pump, 40001-0401 Open, Classified	FRN	K242114
May 18, 2026	ICU Medical, Inc. Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960 Open, Classified	ONB	K131549
Jan 16, 2026	ICU Medical, Inc. Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000 Open, Classified	FPA	K053106
Jan 16, 2026	ICU Medical, Inc. ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines) Open, Classified	FRN	K242114
Jan 16, 2026	ICU Medical, Inc. ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines) Open, Classified	FRN	K242115
Jan 16, 2026	ICU Medical, Inc. ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines) Open, Classified	FRN	K223607
Jan 15, 2026	ICU Medical Inc. Portex Spinal Tray, Item No. A3729-24 A3595 Open, Classified	CAZ	K965017
Jan 15, 2026	ICU Medical Inc. Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG Open, Classified	JKA	K952516
Jan 15, 2026	ICU Medical, Inc. Plum Duo Infusion System, List Number 40002-04-01 Open, Classified	FRN	K223607
Dec 19, 2025	ICU Medical, Inc. LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02 Open, Classified	PHC	K242117
Dec 19, 2025	ICU Medical, Inc. LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02 Open, Classified	PHC	K242117
Oct 27, 2025	ICU Medical, Inc. ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical ChemosafeLock Connecter REF: KL-FNU3 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical ChemoLock w/Mini Bag Spike REF: C-17 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units REF: 011-CL-70S-20 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical ChemoLock Port REF: CL2100 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical ChemoLock Closed Vial Spike REF: CL-80 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33 Open, Classified	ONB	K131549
Oct 27, 2025	ICU Medical, Inc. ICU Medical ChemoLock Bag Spike REF: CL-10 Open, Classified	ONB	K131549

Newest 50 of 656.

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