# K160294: SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Oct 21, 2016 after 261 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: 3 generations back to K932249 (1993). 8 ancestors in all.
3 later devices descend from it; 3 cite it directly.
2 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911260: Atraumatic Standard Sprotte Needle, Pajunk GmbH (1991) Summary page 5.
- K040965: Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles, Pajunk GmbH (2004) Summary page 5.

## Most influential descendants
- K250774: SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture (2025), 0 descendants of its own
- K193131: BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle (2020), 0 descendants of its own
- K170112: IMD's Lumbar Puncture Needle (2018), 0 descendants of its own

## Indications for use
The SPROTTE® NRFit™, Quincke NRFit™ lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography procedures. The device is intended for adult and pediatric patients.

Source page: https://510kreport.com/device/K160294
Methodology: https://510kreport.com/methodology