BD PhaSeal Optima Closed System Transfer Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181221 FDA 510(k)
- FDA Product Code
- ONB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD PhaSeal Optima Closed System Transfer Device is a Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System, designed to prevent exposure to hazardous drugs during preparation, transfer, and administration. It employs a physical barrier technology with self-sealing membrane-to-membrane connections and a vapour-capturing mechanism to maintain an airtight seal, reducing the risk of contamination or leakage.
This single-use device is intended for use in general hospital settings and is supplied sterile. It adheres to FDA 510(k) clearance (K181221) under the General Hospital advisory committee classification, classified as a Class II medical device. Storage and handling must comply with manufacturer guidelines to preserve sterility and functionality, ensuring safe use in clinical workflows.
Frequently asked questions
What is the primary purpose of the BD PhaSeal Optima Closed System Transfer Device in clinical settings?
The BD PhaSeal Optima is designed specifically to minimize exposure to hazardous drugs during preparation, transfer, and administration. It uses a closed-system barrier with self-sealing membrane connections and a vapor-capturing mechanism to maintain an airtight seal, reducing the risk of contamination or leakage during handling of antineoplastic and hazardous medications.
Is the BD PhaSeal Optima Closed System Transfer Device intended for reuse, or is it meant for single-use only?
The device is explicitly labeled as single-use. This ensures sterility and functionality are maintained for one use only, aligning with best practices for hazardous drug handling to prevent cross-contamination and ensure patient safety.
How should the BD PhaSeal Optima be stored to maintain its integrity and sterility?
Storage and handling must follow the manufacturer’s guidelines to preserve sterility and functionality. Since it is supplied sterile, it should be stored in its original packaging until use, protected from physical damage, moisture, and extreme temperatures to ensure it remains effective for its intended clinical workflow.
What regulatory pathway was followed for FDA clearance of the BD PhaSeal Optima?
The device received FDA clearance through a 510(k) submission (K181221) under the General Hospital advisory committee classification, classified as a Class II medical device. The submission was determined to be substantially equivalent to a predicate device, following a traditional review process.
Are there multiple sizes or models of the BD PhaSeal Optima, or is it a single standardized device?
The provided data lists multiple FEI numbers and registration numbers, which typically correspond to different lot or batch identifiers rather than distinct sizes or models. However, the device itself is described as a single product line with standardized closed-system technology for hazardous drug transfer, ensuring consistency in design and function across uses.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD PhaSeal™ Optima System, BD PhaSeal™ Optima System, PDF Becton, Dickinson and Company
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181221 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K181221 24 fields · synced Sep 18, 2026