# K170305: Spinal Manometer NRFit; Spinal Manometer LUER

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Jul 25, 2017 after 175 days
- Product code: FMJ (Manometer, Spinal-Fluid)
- Device class: 2
- Regulation: 21 CFR 880.2500
- 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 K032432 (2003). 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)
- K032432: Busse Hospital Disposables Spinal Manometer, Busse Hospital Disposables, Inc. (2003) Summary page 5.

## Indications for use
The Spinal Manometer NRFit/ Spinal Manometer LUER is intended to measure the pressure of the Cerebrospinal Fluid (CSF) during a lumbar puncture procedure.

Source page: https://510kreport.com/device/K170305
Methodology: https://510kreport.com/methodology