# K250774: SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Jun 25, 2025 after 103 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 7.

## Indications for use
The SPROTTE® STANDARD (LUER/ NRFit®) lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection/ withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography.

Source page: https://510kreport.com/device/K250774
Methodology: https://510kreport.com/methodology