BD Plastipak Syringe
by Becton, Dickinson and Company
510(k) K182589
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK182589 | Date14 Mar 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The BD Plastipak Syringe is a 3-piece hypodermic syringe (Device Type: FMF) designed for accurate and leak-tight medication delivery. Its clear barrel, bold scale markings, and silicone-lubricated plunger facilitate precise dosing and smooth operation, ensuring reliable administration in clinical settings.
This syringe is supplied as a single-use, non-sterile device (unless specified otherwise in sterile packaging) and is intended for use in general hospital procedures. It is available in various capacities, including the 3 mL variant referenced in adverse event reports, and must be handled according to standard aseptic techniques. Regulatory clearance under FDA_510K (K182589) confirms its compliance with U.S. safety and performance standards for medical syringes.
From the manufacturer
Discover BD Plastipak™ 3-Piece Syringe with Luer Lock Tip, clear barrel, bold scale printing, and special silicone lubrication for smooth plunger movement.
Plastipak™ and BD ® Hypodermic Syringes are among the most widely used solutions for precise and reliable medication delivery.¹ Designed to support high-quality care in every procedure, for every patient. Precision matters in medication delivery The drug, capacity range, and timing must be verified with accuracy.² That is why the choice of syringe is just as important.
Other devices from Becton, Dickinson and Company
Questions
AI-generated answers, 18 Sep 2026
What makes the BD Plastipak Syringe suitable for precise medication dosing in clinical settings?
The BD Plastipak Syringe is designed with a clear barrel featuring bold scale markings for easy visibility, ensuring accurate measurement of medication volumes. Additionally, the plunger is silicone-lubricated, which allows for smooth and leak-tight operation, reducing the risk of dosing errors during administration.
Is the BD Plastipak Syringe intended for reuse, or is it meant to be used only once?
The BD Plastipak Syringe is explicitly labeled as a single-use device. While it is typically supplied in non-sterile packaging, it must be handled using standard aseptic techniques to maintain sterility during use. Reuse is not recommended or supported by the manufacturer.
What sizes or capacities are available for the BD Plastipak Syringe, and how might this affect my clinical workflow?
The BD Plastipak Syringe is available in multiple capacities, including a 3 mL variant (as referenced in adverse event reports), among others. The choice of size depends on the volume of medication being administered—smaller sizes (e.g., 1 mL) are ideal for precise dosing of low-volume drugs, while larger sizes (e.g., 10 mL) accommodate higher volumes. The clear barrel and bold markings ensure accurate measurement regardless of size.
How should I store the BD Plastipak Syringe to ensure it remains functional and safe for use?
The BD Plastipak Syringe should be stored in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. If purchased in sterile packaging, it must be kept sealed until use to maintain sterility. Always follow the manufacturer’s instructions for storage, and avoid exposing the syringe to contaminants or moisture that could compromise its integrity.
What regulatory pathway does the BD Plastipak Syringe follow, and what does that mean for its safety and performance?
The BD Plastipak Syringe received FDA 510(k) clearance (K182589) under the Traditional pathway, with a decision classification of Substantially Equivalent (SESE). This means it has been evaluated by the FDA and determined to be as safe and effective as a legally marketed predicate device (a previously cleared syringe). The clearance confirms compliance with U.S. safety and performance standards for medical syringes, ensuring reliability for clinical use.