# K221513: Equashield Closed System Transfer Device

- Pathway: 510(k) (Traditional)
- Applicant: Equashield Medical, Ltd.
- Decided: Feb 17, 2023 after 268 days
- Product code: ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K883614 (1988). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170706: Equashield Closed System drug Transfer Device (CSTD), Equashield Medical, Ltd. (2017) Summary page 4.

## Indications for use
Closed System Drug Transfer Device (CSTD) for safe preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress up to 7 days. The system's closed Syringe Unit prevents intended and unintended syringe plunger detachment and can be used safely up to its maximal nominal volume with hazardous drugs

Source page: https://510kreport.com/device/K221513
Methodology: https://510kreport.com/methodology