ClearanceBrief
510(k) K131549 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

CHEMOLOCK, CHEMOLOCK PORT

ApplicantIcu Medical, Inc., Salt Lake City UT, US
DecisionSubstantially Equivalent, Jul 26, 2013
ReceivedMay 29, 2013
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K131549

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
May 18, 2026ICU 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
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ChemoLock Bag Spike, 01 units REF: CL-10-10
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Bag Spike REF: CL-10
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Closed Vial Spike REF: CL-80
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Port REF: CL2100
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units REF: 011-CL-70S-20
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock w/Mini Bag Spike REF: C-17
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
Open, Classified
ONBNone listed
Oct 27, 2025ICU 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
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
Open, Classified
ONBNone listed
Oct 27, 2025ICU 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
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
Open, Classified
ONBNone listed
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Open, Classified
ONBNone listed
Dec 9, 2024ICU Medical, Inc.
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which wi
Open, Classified
ONBNone listed
Jun 27, 2022ICU Medical, Inc.
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100;
Open, Classified
ONBNone listed
Mar 16, 2021ICU Medical, Inc.
REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: provides access for the administration of fluids from a container
Open, Classified
ONBNone listed
Mar 16, 2021ICU Medical, Inc.
REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-In Red Cap - Product Usage: provides access for the administr
Open, Classified
ONBNone listed
Mar 16, 2021ICU Medical, Inc.
REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a c
Open, Classified
ONBNone listed
Mar 16, 2021ICU Medical, Inc.
REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a c
Open, Classified
ONBNone listed
Mar 16, 2021ICU Medical, Inc.
REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock; Syringe Transfer Set w/MicroClave, w/ChemoLock Port - Product
Open, Classified
ONBNone listed
Mar 16, 2021ICU Medical, Inc.
REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer - Product Usage: provides access for the administratio
Open, Classified
ONBNone listed
Aug 31, 2020ICU Medical, Inc.
30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, S
Open, Classified
ONBNone listed
Apr 15, 2019ICU Medical, Inc.
icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental con
Terminated
FPANone listed
Feb 22, 2019ICU Medical, Inc.
icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants
Terminated
ONBNone listed
Feb 25, 2016ICU Medical, Inc.
74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration sets are intended for the infusion and withdrawal of fluids. Drip Chamber, Rotating Luer, Ba
Terminated
ONBNone listed
Feb 25, 2016ICU Medical, Inc.
30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Bag Hanger, Item No. 011-CL3511 sterile devices intended for the infusion and withdrawal of fluids.
Terminated
ONBNone listed
Feb 25, 2016ICU Medical, Inc.
30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. 011-CL3528 sterile devices intended for the infusion and withdrawal
Terminated
ONBNone listed
Feb 25, 2016ICU Medical, Inc.
110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Clave, Rotating Luer, Bag Hanger, Item No. AHCL3300 sterile devices intended for the infusion and withdrawal of
Terminated
ONBNone listed
Feb 25, 2016ICU Medical, Inc.
30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clerestories devices intended for the infusion and withdrawal of flu
Terminated
ONBNone listed
Feb 25, 2016ICU Medical, Inc.
30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 sterile devices intended for the infusion and withdrawal of fluid
Terminated
ONBNone listed
Feb 25, 2016ICU Medical, Inc.
30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. CL3528 sterile devices intended for the infusion and withdrawal of
Terminated
ONBNone listed
Feb 25, 2016ICU Medical, Inc.
31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Spiros, Bag Hanger, Item No. SL3011 sterile devices intended for the infusion and withdrawal of fluids.
Terminated
ONBNone listed

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