Bd Pen Needle
by Becton, Dickinson & CO 510(k)
Active
510(k) K131358
Overview
The BD Ultra Fine Insulin Pen Needle BDS320119 is a disposable, ultra-fine gauge needle designed for insulin delivery via pen injectors. It is classified as a pen needle and is intended for subcutaneous administration of insulin in diabetic patients, facilitating precise dosing and reduced discomfort during injection.
This single-use device is supplied sterile and packaged individually for clinical use. It is intended for use with insulin pen devices and is not compatible with reusable systems. The BDS320119 has received FDA 510(k) clearance under the General Hospital advisory committee review, ensuring compliance with regulatory standards for medical devices in the United States.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131358 | Date16 Jul 2013 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FMI
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5570
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Becton, Dickinson & Co.
Questions
What types of insulin pen devices is the BD Ultra Fine Insulin Pen Needle (BDS320119) designed to work with, and why is it not suitable for reusable systems?
The BD Ultra Fine Insulin Pen Needle (BDS320119) is specifically designed for use with insulin pen *injectors*—not reusable systems. It is a single-use, disposable needle, meaning it is intended for one-time clinical use only. This design choice ensures sterility and safety, as reusable systems carry risks of contamination or damage over time. The needle’s compatibility is limited to disposable pen injectors, which aligns with its sterile, individual packaging and ultra-fine gauge for precise subcutaneous insulin delivery.
How is the sterility of the BD PEN NEEDLE (BDS320119) maintained, and what does this mean for clinical use?
The BD Ultra Fine Insulin Pen Needle (BDS320119) is supplied *sterile* and packaged individually for clinical use. This means each needle is sealed in a sterile barrier to prevent contamination before use, ensuring a clean injection site for diabetic patients. Clinicians can rely on this sterility to reduce infection risks when administering insulin, as the needle is not intended for reuse and must remain unopened until immediate use.
Are there different sizes or models of the BD PEN NEEDLE, and if so, how can I identify the correct one for my insulin pen?
The provided data only specifies one model of the BD Ultra Fine Insulin Pen Needle: the BDS320119. This is an ultra-fine gauge needle designed for insulin delivery via pen injectors. Since no other sizes or models are mentioned, you should confirm compatibility with your specific insulin pen device’s manufacturer guidelines. The needle’s fine gauge is intended to minimize discomfort during subcutaneous insulin administration, so ensure your pen system supports this model.
What regulatory pathway did the BD PEN NEEDLE (BDS320119) follow to gain market authorization in the U.S., and what does this mean for its safety?
The BD Ultra Fine Insulin Pen Needle (BDS320119) received FDA 510(k) clearance under the General Hospital (HO) advisory committee review, classified as *substantially equivalent* to a predicate device. This means the FDA evaluated it against existing, legally marketed pen needles to ensure it meets safety and performance standards without requiring a full de novo review. Clinicians can trust this pathway confirms the needle’s design and manufacturing align with regulatory expectations for insulin delivery devices.