# K160295: SPROTTE NRFit, Quincke NRFit

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Oct 27, 2016 after 267 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.
1 later device descends from it; 1 cites it directly.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911202: Atraumatic Standard Sprotte Needle, Pajunk GmbH (1992) Summary page 5.
- K040965: Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles, Pajunk GmbH (2004) Summary page 5.

## Most influential descendants
- K241953: SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (2024), 0 descendants of its own

## Indications for use
The SPROTTE® NRFit™, Quincke NRFit™ needles are anesthesia conduction needles which are used to administer anesthetic agent to the subarachnoid space. The device is intended for adult and pediatric patients.

Source page: https://510kreport.com/device/K160295
Methodology: https://510kreport.com/methodology