510(k) K131549 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
CHEMOLOCK, CHEMOLOCK PORT
| Applicant | Icu Medical, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jul 26, 2013 |
| Received | May 29, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131549
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | ICU Medical, Inc. Oncology sets with drip chambers Open, Classified |
ONB | None listed |
| Sep 11, 2026 | ICU Medical, Inc. IV Sets with drip chambers Open, Classified |
ONB | None listed |
| 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 | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ChemoLock Bag Spike, 01 units
REF: CL-10-10 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
Chemo Lock Universal Vented Vial Spike
REF: CL-70-10 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemoLock" Port, Bulk, Non-Sterile
REF: CL2100-NS Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
Clave Bag Spike w/ChemoLock Port
REF: CL2150 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU 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 |
ONB | None listed |
| Oct 27, 2025 | ICU 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 |
ONB | None listed |
| Oct 27, 2025 | ICU 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 |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemoLock Bag Spike with Clave Additive Port
REF: CL3940 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
Oncology Kit w/ChemoLock, ChemoLock Port
REF: CL4136 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port
REF: CL4138 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU 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 |
ONB | None listed |
| Oct 27, 2025 | ICU 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 |
ONB | None listed |
| Oct 27, 2025 | ICU 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 |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemoLock Bag Spike
REF: CL-10 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
Double ChemoLock Port Syringe Transfer Set
REF: CL-33 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemoLock Universal Vented Vial Spike
REF: CL-70 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemoLock Vented Vial Spike, 20mm
REF: CL-70S Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemoLock Vented Vial Spike, 13mm
REF: CL-72 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemoLock Closed Vial Spike
REF: CL-80 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemoLock Vial Spike, 20mm
REF: CL-80S Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemoLock Closed Vial Spike w/Skirt, 5 Units
REF: CL-80S-5 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemoLock 13mm Closed Vial Spike
REF: CL-82 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemoLock Port
REF: CL2100 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector
REF: CL3360 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
Graduated Connector w/ChemoLock Port
REF: CL3900 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port
REF: CL3955 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemoLock Vented Vial Spike, 20mm, 20 Units
REF: 011-CL-70S-20 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemoLock w/Mini Bag Spike
REF: C-17 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
Syringe Transfer Set w/MicroClave, ChemoLock Port
REF: CL-34 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemoLock Port w/Spiros, Red Cap
REF: CL-35 Open, Classified |
ONB | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemosafeLock Bag Spike
REF: KL-BS001U3 Open, Classified |
ONB | None listed |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemosafeLock Connecter
REF: KL-FNU3 Open, Classified |
ONB | None listed |
| 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 | None listed |
| Dec 9, 2024 | ICU 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 |
ONB | None listed |
| Jun 27, 2022 | ICU 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 |
ONB | None listed |
| Mar 16, 2021 | ICU 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 |
ONB | None listed |
| Mar 16, 2021 | ICU 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 |
ONB | None listed |
| Mar 16, 2021 | ICU 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 |
ONB | None listed |
| Mar 16, 2021 | ICU 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 |
ONB | None listed |
| Mar 16, 2021 | ICU 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 |
ONB | None listed |
| Mar 16, 2021 | ICU 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 |
ONB | None listed |
| Aug 31, 2020 | ICU 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 |
ONB | None listed |
| Apr 15, 2019 | ICU 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 |
FPA | None listed |
| Feb 22, 2019 | ICU 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 |
ONB | None listed |
| Feb 25, 2016 | ICU 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 |
ONB | None listed |
| Feb 25, 2016 | ICU 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 |
ONB | None listed |
| Feb 25, 2016 | ICU 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 |
ONB | None listed |
| Feb 25, 2016 | ICU 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 |
ONB | None listed |
| Feb 25, 2016 | ICU 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 |
ONB | None listed |
| Feb 25, 2016 | ICU 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 |
ONB | None listed |
| Feb 25, 2016 | ICU 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 |
ONB | None listed |
| Feb 25, 2016 | ICU 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 |
ONB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.