# K140591: BD Phaseal Closed System Transfer Device - Injector

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson & CO
- Decided: May 14, 2014 after 68 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: 1 (0 Class I)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 16 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 1.

## Most influential descendants
- K150486: Halo (2015), 1 descendant of its own
- K180574: Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor (2018), 0 descendants of its own

## Recalls of this device
- Jun 16, 2025 · Class II · Z-2453-2025: Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.

## Indications for use
The PhaSeal system is an airtight and leakproof closed system drug transfer device (CSTD) that 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. The PhaSeal system also prevents microbial ingress.

Source page: https://510kreport.com/device/K140591
Methodology: https://510kreport.com/methodology