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BD PhaSeal Optima Closed System Drug Transfer Device

by Becton, Dickinson and Company

510(k) K201099

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK201099 Date12 Aug 2020ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2453-2025 FDA Class II initiated 16 Jun 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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ONB
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BD PhaSeal Optima Closed System Drug Transfer Device is a Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System, designed to prevent environmental contamination during the handling of hazardous drugs. It employs a sealed, airtight mechanism to minimize exposure risks to healthcare personnel while facilitating safe drug transfer and reconstitution. The device adheres to closed-system principles, ensuring containment of drug vapors and particulates within the system.

This device is intended for single-use in hospital pharmacy and clinical settings, where hazardous drugs are prepared or transferred. Supplied sterile and packaged individually, it requires no additional sterilization. The system is classified as Class II under FDA regulations and has received FDA 510K clearance (K201099) as substantially equivalent to prior-generation CSTDs. Compliance with 21 CFR 880.5440 ensures adherence to regulatory standards for hazardous drug handling.

From the manufacturer

The BD PhaSeal™ System pioneered the category of closed-system drug-transfer devices (CSTDs) to help protect the pharmacists and clinicians who prepare and administer hazardous drugs. Twenty years later, we turned to healthcare professionals like you for feedback and guidance to optimize its every component.

Source: bd.com

The next-generation Closed-System Drug-Transfer Device (CSTD) from BD that advances hazardous drug protection.

Source: bd.com

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Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of settings is the BD PhaSeal Optima designed for, and how does it help in those environments?

    The BD PhaSeal Optima is specifically designed for hospital pharmacy and clinical settings where hazardous drugs—such as antineoplastics—are prepared, reconstituted, or transferred. It minimizes exposure risks to healthcare personnel by maintaining a sealed, airtight system that contains drug vapors and particulates, ensuring safer handling in environments where contamination is a critical concern.

  • Is the BD PhaSeal Optima reusable, or is it intended for single-use only?

    The BD PhaSeal Optima is explicitly intended for single-use only. It is supplied sterile and packaged individually, eliminating the need for additional sterilization between uses. This design aligns with best practices for hazardous drug handling to prevent cross-contamination and ensure patient and staff safety.

  • How is the BD PhaSeal Optima regulated, and what does its FDA clearance status mean for buyers?

    The BD PhaSeal Optima received FDA 510(k) clearance (K201099) under the Special 510(k) Review pathway, classified as a Class II device. This clearance confirms it is substantially equivalent to prior-generation Closed System Drug Transfer Devices (CSTDs), meeting regulatory standards for hazardous drug containment. Buyers can rely on this approval for compliance with 21 CFR 880.5440, ensuring adherence to safety and containment requirements in pharmacy and clinical workflows.

  • What are the key features that distinguish the BD PhaSeal Optima from other closed-system drug transfer devices?

    The BD PhaSeal Optima is a Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System that prioritizes sealed containment to prevent environmental exposure during drug handling. Unlike some alternatives, it is pre-sterilized and single-use, reducing the risk of contamination and eliminating the need for reprocessing. Its airtight mechanism ensures drug vapors and particulates remain within the system, addressing a core safety gap in hazardous drug preparation.

  • How should the BD PhaSeal Optima be stored, and are there any specific handling instructions for unopened units?

    The device is supplied sterile and individually packaged, so unopened units should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow manufacturer guidelines for shelf-life and expiration dates printed on the packaging. Since it’s single-use, avoid opening or handling until immediate use to maintain sterility and integrity for safe hazardous drug transfer.