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Panels › General Hospital › Product code ONB · Class 2

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Regulation 880.5440

1510(k)s in 12 months (41 all time)
3recalls in 12 months (73 all time)
69recalls that name a 510(k)
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Top companies in ONB

DateFirm and productCodeLinked 510(k)
Sep 11, 2026ICU Medical, Inc.
IV Sets with drip chambers
Open, Classified
ONBK131549
K170110 +1
Sep 11, 2026ICU Medical, Inc.
Oncology sets with drip chambers
Open, Classified
ONBK131549
K173477
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
ONBK131549
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
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
Open, Classified
ONBK131549
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
ONBK131549
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
ONBK131549
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
ONBK131549
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
ONBK131549
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
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock w/Mini Bag Spike REF: C-17
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units REF: 011-CL-70S-20
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Port REF: CL2100
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Closed Vial Spike REF: CL-80
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Bag Spike REF: CL-10
Open, Classified
ONBK131549
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
ONBK131549
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
ONBK131549
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
ONBK131549
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
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
Open, Classified
ONBK131549
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
ONBK131549
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
ONBK131549
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
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
Open, Classified
ONBK131549
Oct 27, 2025ICU Medical, Inc.
ChemoLock Bag Spike, 01 units REF: CL-10-10
Open, Classified
ONBK131549
Aug 27, 2025BD SWITZERLAND SARL
BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 51500
Open, Classified
ONBK123213
K130197 +3
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
ONBK131549
Nov 3, 2023B. Braun Medical, Inc.
THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.
Open, Classified
ONBNone listed
Jul 18, 2022Becton Dickinson & Company
BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the es
Open, Classified
ONBK123213
Jun 27, 2022ICU Medical, Inc.
Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike/CL-17; 8 IN (20cm) APPX 1.0ml, EXT SET, MicroClave Clear, ChemoLock PORT, YCONN/C
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
ONBK131549
Mar 8, 2022SIMPLIVIA HEALTHCARE LTD.
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Open, Classified
ONBK192866
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
ONBK173477
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
ONBK173477

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