BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K193131 ↗

FDA Product Code

BSP

Device Class

Class II

Regulation

21 CFR Part 868.5150

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• BD Vacutainer® Serum Blood Collection Tubes

  Class II

  FDA 510(k) K252344 Active Cleared 16 Oct 2026

• BACTEC MicroMGIT

  Class A

  CE/IVDR

• Phoenix

  Class B

  CE/IVDR

• Max

  Class A

  CE/IVDR

• Vacutainer Barricor

  Class A

  CE/IVDR

• Vacutainer

  Class IIa

  CE/MDR

See all devices from Becton, Dickinson and Company →

• What are the key differences between the BD Quincke Spinal NRFit Needle and the BD Whitacre Spinal NRFit Needle in terms of size and design?

  The BD Quincke Spinal NRFit Needle offers a wider range of lengths (76.2 mm to 177.8 mm) and gauges (18 G to 27 G), making it suitable for varied spinal procedures. In contrast, the BD Whitacre Spinal NRFit Needle has a shorter length range (88.9 mm to 119.1 mm) but includes a thinner-walled variant, which may reduce resistance during insertion while maintaining gauges from 22 G to 27 G. The Whitacre design is often preferred for its reduced trauma to the dura.

• Are these needles intended for reuse, or are they strictly single-use instruments? Why does this matter?

  These needles are explicitly designed as single-use instruments. This matters because single-use devices minimize the risk of cross-contamination and infection, which is critical in spinal procedures where sterile conditions are non-negotiable. Reuse could compromise sterility and patient safety, especially in procedures involving cerebrospinal fluid or anesthesia delivery.

• What storage conditions should be followed for these needles, and why is this important?

  While the data does not specify exact storage conditions, all needles are supplied sterile and should be stored in a clean, dry environment protected from moisture, dust, and extreme temperatures. Proper storage ensures sterility is maintained until use, preventing contamination that could compromise the integrity of the needle or introduce infection risks during spinal procedures.

• How do I determine which gauge or length is best for a specific spinal procedure, such as a lumbar puncture?

  The choice depends on the procedure’s requirements and patient anatomy. For lumbar punctures, a 22–25 G needle (e.g., BD Whitacre or Quincke) is commonly used due to its balance of ease of insertion and reduced trauma. Lengths typically range from 88.9 mm to 119.1 mm for adults, but the Quincke’s longer options (up to 177.8 mm) may be needed for pediatric cases or deeper targets. Consulting clinical guidelines or your facility’s standard protocols is recommended to match the needle to the patient’s size and procedure specifics.

• What regulatory pathway was followed for FDA clearance of these needles, and what does that mean for clinicians?

  These needles were cleared via the FDA 510(k) pathway, specifically under the Anesthesiology advisory committee (AN), with a determination of substantial equivalence (SE) to predicate devices. This means the FDA reviewed their design, performance, and safety data to confirm they meet established standards for conduction needles used in anesthesia and spinal procedures. Clinicians can rely on this clearance as evidence that the devices comply with FDA requirements for their intended use in spinal procedures.