ClearanceBrief
510(k) K173477 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

ChemoCLAVE Cytotoxic Medication Preparation and Delivery System

ApplicantIcu Medical, Inc., Lake Forest IL, US
DecisionSubstantially Equivalent, Aug 31, 2018
ReceivedNov 13, 2017
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K173477

DateFirm and productCodeLinked 510(k)
Sep 11, 2026ICU Medical, Inc.
Oncology sets with drip chambers
Open, Classified		 ONBNone listed
Sep 11, 2026ICU Medical, Inc.
IV Sets with drip chambers
Open, Classified		 ONBNone listed
Mar 16, 2021ICU Medical, Inc.
REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s ne
Open, Classified		 ONBNone listed
Mar 16, 2021ICU Medical, Inc.
REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s ne
Open, Classified		 ONBNone listed
Mar 16, 2021ICU Medical, Inc.
REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a cont
Open, Classified		 ONBNone listed
Mar 16, 2021ICU Medical, Inc.
REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular
Open, Classified		 ONBNone listed
Mar 16, 2021ICU Medical, Inc.
REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administration of fluids from a
Open, Classified		 ONBNone listed
Aug 31, 2020ICU Medical, Inc.
3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, REF: CH2010; 20mL Syringe w/Spinning Spiros, Red Cap,
Open, Classified		 ONBNone listed
Jul 6, 2020ICU Medical, Inc.
6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap;1 unit per pouch, 50 pouches per case. UDI:(01)10887709098878(17)241201(30)50(10)4493149. The ChemoClave is a
Terminated		 FPANone listed

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