# K123213: BD Phaseal Closed System Transfer Device

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jan 9, 2013 after 86 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K883614 (1988). 12 ancestors in all.
34 later devices descend from it; 9 cite it directly.
1 of 47 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120384: Protector, Injector, Connector, Bd Medical-Medical Surgical Systems (2012) Summary page 1.

## Most influential descendants
- K130197: BD Phaseal Closed System Transfer Device - P55 (2013), 19 descendants of its own
- K131549: Chemolock, Chemolock Port (2013), 10 descendants of its own
- K141448: Tevadaptor Closed Drug Reconstitution and Transfer System (2015), 9 descendants of its own
- K132899: Equashield Closed System Drug Transfer Device (CSTD) (2014), 6 descendants of its own
- K170706: Equashield Closed System drug Transfer Device (CSTD) (2017), 5 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.
- Jul 18, 2022 · Class II · Z-1555-2022: Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product.

## 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/K123213
Methodology: https://510kreport.com/methodology