# K192075: ProSeal™ Closed System drug Transfer Device (CSTD)

- Pathway: 510(k) (Traditional)
- Applicant: Epic Medical Pte., Ltd.
- Decided: Aug 7, 2020 after 371 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: 7 generations back to K883614 (1988). 13 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123213: BD Phaseal Closed System Transfer Device, Becton, Dickinson & CO (2013) Summary page 4.

## Most influential descendants
- K240171: ProSeal™ Injector Plus (Model no. 421050) (2024), 3 descendants of its own
- K251722: ProSeal™ Transfer Injector (421120, 421130, 421140) (2025), 0 descendants of its own
- K241735: ProSeal™ In Line Pump Set (423850) (2024), 0 descendants of its own
- K240433: ProSeal™ Injection Site Extended Male Luer Lock (422140) (2024), 0 descendants of its own

## Indications for use
The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

Source page: https://510kreport.com/device/K192075
Methodology: https://510kreport.com/methodology