# K150219: Equashield Closed System drug Transfer Device (CSTD)

- Pathway: 510(k) (Traditional)
- Applicant: Equashield Medical, Ltd.
- Decided: Nov 5, 2015 after 279 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K170706: Equashield Closed System drug Transfer Device (CSTD) (2017), 5 descendants of its own
- K201460: Closed System Transfer Device (2022), 3 descendants of its own
- K241988: ProSeal™ Closed System Bag Access (2024), 2 descendants of its own
- K251340: ProSeal™ Bag Spike with Additive Port (423370ST, 423370) (2025), 0 descendants of its own
- K243976: ZeroClear™ Bag Access (423100) (2025), 0 descendants of its own

## Indications for use
Closed System drug Transfer Device (CSTD) for 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.

Source page: https://510kreport.com/device/K150219
Methodology: https://510kreport.com/methodology