# K201460: Closed System Transfer Device

- Pathway: 510(k) (Traditional)
- Applicant: Shinva Ande Healthcare Apparatus Co., Ltd.
- Decided: Nov 23, 2022 after 904 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.
3 later devices descend from it; 1 cites it directly.
0 of 30 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 5.

## Most influential descendants
- 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
The Closed System 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.

Source page: https://510kreport.com/device/K201460
Methodology: https://510kreport.com/methodology