BD Hypodermic Syringe
by Becton, Dickinson and Company
510(k) K203453
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK203453 | Date25 Jan 2021 | 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- Withdrawn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 Hypodermic Syringe is a hypodermic syringe (Device Type: FMF) designed for the administration of liquids into or withdrawal from the human body. It features a plunger mechanism to draw, hold, and dispense precise volumes of fluids, commonly used for injections, infusions, or blood draws. Constructed with materials suitable for sterile medical use, it adheres to standards for single-use disposable devices.
This syringe is supplied sterile, intended for single-use only, and must be discarded after use to prevent contamination. It is not MRI-safe and is available in various sizes as specified in the product line. Authorized under FDA 510K clearance (K203453), it complies with regulatory requirements for hypodermic syringes in the General Hospital category. Storage instructions and size specifications are detailed in the manufacturer’s documentation.
From the manufacturer
A legacy of performance and trust #1 selling needle and syringe portfolio in the U.S.
BD Conventional Needles and Syringes are designed and manufactured to deliver this kind of consistent quality and reliable performance. The result of our commitment is a portfolio of hypodermic solutions more widely used by healthcare professionals globally than any other company.
Other devices from Becton, Dickinson and Company
Questions
AI-generated answers, 18 Sep 2026
What types of medical procedures is the BD Hypodermic Syringe commonly used for?
The BD Hypodermic Syringe is primarily designed for administering liquids into or withdrawing fluids from the human body, making it suitable for procedures like injections (e.g., vaccines, medications), infusions, and blood draws. Its precise plunger mechanism ensures accurate dosing, which is critical for these applications.
Is the BD Hypodermic Syringe reusable, or is it meant for single-use only?
The BD Hypodermic Syringe is explicitly intended for single-use only and must be discarded after use to prevent contamination. This aligns with standard medical practice for hypodermic syringes to ensure patient safety and sterility.
How should I store the BD Hypodermic Syringe before use, and does it come pre-sterilized?
The syringe is supplied sterile and requires adherence to the manufacturer’s storage instructions, which are detailed in their documentation. Proper storage ensures sterility is maintained until use. Since it’s single-use, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures.
Are there multiple sizes available for the BD Hypodermic Syringe, and how do I determine the right one for my needs?
Yes, the BD Hypodermic Syringe is available in various sizes, though the exact specifications (e.g., volume ranges like 1 mL, 3 mL, 5 mL, etc.) are outlined in the manufacturer’s product line documentation. The correct size depends on the volume of fluid being administered or withdrawn—smaller syringes (e.g., 1 mL) are ideal for precise injections, while larger ones (e.g., 10 mL) may be used for blood draws or higher-volume infusions.
Can this syringe be used in an MRI environment, or are there any safety concerns?
The BD Hypodermic Syringe is not MRI-safe, meaning it should not be used in or near an MRI machine. The materials or components may react to the magnetic field, posing a risk to both the device and the patient. Always verify compatibility with MRI procedures before use.