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)
Top companies in ONB
| Company | 510(k)s | Recalls |
|---|---|---|
| Icu Medical | 4 | 68 |
| Epic Medical Pte. , Ltd. | 12 | 0 |
| Simplivia Healthcare , Ltd. | 6 | 1 |
| Becton, Dickinson and Company | 4 | 0 |
| Equashield Medical , Ltd. | 4 | 0 |
| Becton, Dickinson & CO | 2 | 1 |
| Teva Medical Ltd., Migada Plant | 3 | 0 |
| J & J Solutions, Inc. D/B/A/ Corvida Medical | 2 | 0 |
| B. Braun Medical, Inc. | 0 | 1 |
| BD SWITZERLAND SARL | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | ICU Medical, Inc. IV Sets with drip chambers Open, Classified |
ONB | K131549 K170110 +1 |
| Sep 11, 2026 | ICU Medical, Inc. Oncology sets with drip chambers Open, Classified |
ONB | K131549 K173477 |
| 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 |
| 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 |
| 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 | K131549 |
| 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 | K131549 |
| 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 | K131549 |
| 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 | K131549 |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
Oncology Kit w/ChemoLock, ChemoLock Port
REF: CL4136 Open, Classified |
ONB | K131549 |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemoLock Bag Spike with Clave Additive Port
REF: CL3940 Open, Classified |
ONB | K131549 |
| 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 | K131549 |
| 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 | K131549 |
| 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 | K131549 |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
Clave Bag Spike w/ChemoLock Port
REF: CL2150 Open, Classified |
ONB | K131549 |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
ChemoLock" Port, Bulk, Non-Sterile
REF: CL2100-NS Open, Classified |
ONB | K131549 |
| Oct 27, 2025 | ICU Medical, Inc. ICU Medical
Chemo Lock Universal Vented Vial Spike
REF: CL-70-10 Open, Classified |
ONB | K131549 |
| Oct 27, 2025 | ICU Medical, Inc. ChemoLock Bag Spike, 01 units
REF: CL-10-10 Open, Classified |
ONB | K131549 |
| Aug 27, 2025 | BD 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 |
ONB | K123213 K130197 +3 |
| 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 | K131549 |
| Nov 3, 2023 | B. 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 |
ONB | None listed |
| Jul 18, 2022 | Becton 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 |
ONB | K123213 |
| Jun 27, 2022 | ICU 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 |
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 | K131549 |
| Mar 8, 2022 | SIMPLIVIA HEALTHCARE LTD. OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143 Open, Classified |
ONB | K192866 |
| Mar 16, 2021 | ICU 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 |
ONB | K173477 |
| Mar 16, 2021 | ICU 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 |
ONB | K173477 |
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