# K193131: BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Sep 29, 2020 after 322 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K932249 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160294: SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles, PAJUNK GmbH Medizintechnologie (2016) Summary page 5.

## Indications for use
The BD® Spinal Introducer NRFit™ Needle is intended for placement or introduction of spinal needles. This device is intended for adult and pediatric patients. The BD® Quincke Spinal NRFit™ Needle and BD® Whitacre Spinal NRFit™ Needle are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture and myelography procedures. These devices are intended for adult and pediatric patients.

Source page: https://510kreport.com/device/K193131
Methodology: https://510kreport.com/methodology