# K201099: BD PhaSeal Optima Closed System Drug Transfer Device

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson and Company
- Decided: Aug 12, 2020 after 110 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: 8 generations back to K883614 (1988). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181221: BD PhaSeal Optima Closed System Transfer Device, Becton, Dickinson and Company (2018) Summary page 4.

## 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 BD PhaSeal™ Optima 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 vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The BD PhaSeal™ Optima system also prevents microbial ingress for up to 168 hours.

Source page: https://510kreport.com/device/K201099
Methodology: https://510kreport.com/methodology