BD Ultra-Fine III Pen Needle

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K024109 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• What makes the BD Ultra-Fine III Pen Needle suitable for pediatric patients compared to other insulin delivery needles?

  The BD Ultra-Fine III Pen Needle is designed with a 31-gauge (31G) fine gauge and a short length of 5/16 inch (8mm), which minimizes discomfort and reduces the risk of accidental intramuscular injection. This combination is particularly beneficial for pediatric patients, as it ensures smoother penetration into the subcutaneous fat layer while causing less pain or trauma to delicate skin.

• How should the BD Ultra-Fine III Pen Needle be stored to maintain its sterility and performance?

  The needle must be stored in a way that prevents contamination and exposure to extreme temperatures. Since it is sterile and intended for single-use only, it should remain in its original packaging until use. Standard medical device storage protocols—such as keeping it in a clean, dry environment away from direct sunlight or moisture—should be followed to preserve its integrity.

• Is this needle compatible with all insulin pen injectors, or are there specific models it works with?

  The BD Ultra-Fine III Pen Needle is designed specifically for use with insulin pen injectors, but compatibility depends on the manufacturer’s specifications for their pen system. While it is engineered to fit standard insulin pens, users should verify compatibility with their particular device to ensure proper function and safety.

• Why is the BD Ultra-Fine III Pen Needle considered single-use only, and what happens if it’s reused?

  The needle is intended for single-use only to ensure sterility and safety. Reusing it increases the risk of contamination, infection, or damage to the needle tip, which could compromise insulin delivery accuracy and patient safety. The design and manufacturing standards (including FDA-cleared processes) assume one-time use to maintain performance and reliability.

• What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for users?

  The BD Ultra-Fine III Pen Needle received FDA clearance via a Special 510(k) route, reviewed by the General Hospital Orthopaedic Devices Panel (HO). This means the device was determined to be substantially equivalent to a legally marketed predicate, ensuring it meets established safety and effectiveness standards for insulin delivery needles. Users can rely on this clearance as evidence of regulatory scrutiny for its design and performance.