Identifiers
- 510(k) Number
- K251350 FDA 510(k)
- FDA Product Code
- FMF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Plastipak Syringe is a Plastic Syringe (Nomenclature: FMF), designed for the precise measurement and administration of liquids in clinical settings. Constructed with a single-piece or multi-piece plastic barrel, it features a plunger mechanism for controlled fluid displacement, commonly used for injections, infusions, or sample collection.
Supplied as a sterile, single-use device, the BD Plastipak Syringe is intended for use in general hospital environments. Available in various sizes (e.g., 3 mL), it adheres to FDA clearance under 510(k) K251350 and is classified under the General Hospital advisory committee category. Storage requires protection from contamination and extreme temperatures, as specified in manufacturer guidelines.
Frequently asked questions
What clinical scenarios is the BD Plastipak™ Syringe most commonly used for?
The BD Plastipak™ Syringe is primarily designed for precise liquid measurement and administration in clinical settings, such as injections, infusions, or sample collection. Its single-use, sterile construction makes it suitable for general hospital environments where controlled fluid displacement is required, like administering medications, drawing blood, or preparing intravenous solutions.
Is the BD Plastipak™ Syringe reusable, or is it meant for single-use only?
The BD Plastipak™ Syringe is explicitly labeled as a sterile, single-use device, meaning it is intended for one-time use only. Reusing it could compromise sterility and patient safety, so adherence to single-use guidelines is critical.
What sizes are available for the BD Plastipak™ Syringe, and how do I know which one to choose?
The BD Plastipak™ Syringe is available in multiple sizes, including a 3 mL model (as referenced in the data). The appropriate size depends on the volume of liquid being administered or collected—smaller syringes (like 3 mL) are ideal for precise dosing (e.g., insulin or vaccines), while larger sizes may be used for infusions or sample collection. Always match the syringe size to the clinical procedure requirements.
How should I store the BD Plastipak™ Syringe to maintain its integrity?
Storage of the BD Plastipak™ Syringe requires protection from contamination and extreme temperatures to preserve sterility and functionality. Follow manufacturer guidelines, which likely include keeping it in a sealed, clean environment away from direct sunlight or heat sources. Avoid storing in humid or dirty areas to prevent degradation or microbial growth.
What regulatory pathway was followed for FDA clearance of the BD Plastipak™ Syringe?
The BD Plastipak™ Syringe received FDA clearance via a 510(k) submission (K251350), classified under the General Hospital advisory committee (HO). The device was determined to be substantially equivalent to a legally marketed predicate, following a traditional review process. This clearance confirms its compliance with FDA standards for plastic syringes (product code FMF).
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: MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY 3ml BD ..., BD (company) - Wikipedia, PDF TECHNICAL DATA SHEET Plastipak™ syringes without needles and BD General ..., Becton Dickinson – Wikipedia, Becton Dickinson® Plastipak™ 3-Piece Syringes with Luer-Lok™ Tip
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251350 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K251350 24 fields · synced Sep 18, 2026