Home / 510(k) Clearances / K221513

510(k) K221513

Equashield Closed System Transfer Device by Equashield Medical , Ltd. — Product Code ONB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2023
Date Received
May 25, 2022
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 Equashield Medical , Ltd.

  • K170706 — Equashield Closed System drug Transfer Device (CSTD) (July 3, 2017)
  • K150219 — Equashield Closed System drug Transfer Device (CSTD) (November 5, 2015)
  • K132899 — EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) (May 13, 2014)
  • K101940 — EQUASHIELD SYSTEM PROTECTIVE PLUS (November 19, 2010)

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)