# K210978: BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Dec 22, 2021 after 265 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: 1 generation back to K091758 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091758: BD Spinal Needle 27G, Becton Dickson & Co. (2009) Summary page 5.

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

Source page: https://510kreport.com/device/K210978
Methodology: https://510kreport.com/methodology