Bd Hypoint Needle
by Becton, Dickinson & CO 510(k)
Active
510(k) K070440
Overview
The BD Hypoint Needle 300253 is a hypodermic, single-lumen needle designed for fluid injection and aspiration. Classified under product code FMI, it is intended for use with syringes and injection devices in general medical procedures. Its construction ensures compatibility with standard syringe systems, facilitating precise administration or withdrawal of fluids.
This device is supplied as a single-use, non-sterile item (unless sterilized by the user) and is regulated under FDA 510(k) clearance (K070440) as a Class II medical device under Special Controls. It is intended for general hospital use and must be handled in accordance with sterile technique if used in clinical settings. No MRI safety information is specified, and storage should follow manufacturer guidelines to maintain integrity.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070440 | Date16 Mar 2007 | 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- Withdrawn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
Is the BD Hypoint Needle designed for reuse in clinical settings, or is it meant to be used only once per patient?
The BD Hypoint Needle is explicitly labeled as a single-use device. While it is non-sterile as supplied, it must be handled with sterile technique if used clinically, implying it is intended for one-time use per patient to maintain safety and infection control standards.
How should I store the BD Hypoint Needle to ensure it remains effective and intact before use?
The device should be stored following the manufacturer’s guidelines to preserve its integrity. Since no specific storage conditions are detailed beyond general handling, it’s recommended to keep it in a clean, dry environment away from direct sunlight or extreme temperatures, as with most medical devices. Avoid contamination or physical damage to the needle tip.
Can this needle be used with any syringe, or are there compatibility restrictions I should be aware of?
The BD Hypoint Needle is designed for compatibility with standard syringe systems, ensuring it fits and functions correctly with most general-purpose syringes and injection devices. However, always verify the manufacturer’s instructions for your specific syringe model to confirm a secure fit and prevent leaks or damage.
Is the BD Hypoint Needle sterile when packaged, or does the user need to sterilize it before use?
The needle is supplied as non-sterile unless the user performs sterilization. For clinical use, it must be handled with sterile technique, meaning the user is responsible for ensuring proper sterilization (e.g., via autoclave or other validated methods) before administration to meet infection control standards.
What types of medical procedures is this needle intended for, and are there any specific limitations to its use?
The BD Hypoint Needle is classified under product code FMI and is intended for general medical procedures involving fluid injection or aspiration, such as vaccinations, IV administration, or diagnostic sampling. It is not specified for high-pressure applications or specialized procedures, so standard precautions and sterile technique should always be followed.