510(k) K131549

CHEMOLOCK, CHEMOLOCK PORT by Icu Medical, Inc. — Product Code ONB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 26, 2013
Date Received: May 29, 2013
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class: Class II
Regulation Number: 880.5440
Review Panel: HO
Submission Type

Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.

Other clearances by Icu Medical, Inc.

K250616 — Clave Neutral-Displacement Needlefree Connectors (June 5, 2025)
K242117 — LifeShield Infusion Safety Software Suite (April 2, 2025)
K242114 — Plum Solo Precision IV Pump (April 2, 2025)
K242115 — Plum Duo Precision IV Pump (April 2, 2025)
K243985 — Rio Drug Reconstitution Transfer Device (January 22, 2025)
K232048 — Cogent Hemodynamic Monitoring System; Cogent HMS (December 20, 2023)
K223607 — Plum Duo Infusion System (August 24, 2023)
K223606 — LifeShield Infusion Safety Software Suite (August 24, 2023)
K192154 — Rio Vial-to-Bag Drug Reconstitution Device (April 20, 2020)
K190918 — SwabTip Male Disinfectant Cap (March 6, 2020)

Other clearances for product code ONB

K251722 — ProSeal Transfer Injector (421120, 421130, 421140) (December 5, 2025)
K253033 — Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor (October 21, 2025)
K250059 — BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) (September 12, 2025)
K251411 — Chemfort Female Luer Lock Adaptor (August 5, 2025)
K251340 — ProSeal Bag Spike with Additive Port (423370ST, 423370) (May 29, 2025)
K243976 — ZeroClear Bag Access (423100) (January 22, 2025)
K240517 — ProSeal Vented Universal Vial Adaptor (December 26, 2024)
K241988 — ProSeal Closed System Bag Access (October 23, 2024)
K241735 — ProSeal In Line Pump Set (423850) (October 10, 2024)
K241823 — ToxiSeal Vial Adaptor (August 30, 2024)