# K170435: NerveGuard NRFit, NerveGuard LUER

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Jul 12, 2017 after 149 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 K031128 (2004). 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)
- K031128: B-Smart, Model B-01, Macosta Medical USA, LLC (2004) Summary page 5.

## Indications for use
The NerveGuard Nerve Block Injection Pressure Limiter is a disposable manometer for measuring injection pressure during administration of peripheral nerve blocks.

Source page: https://510kreport.com/device/K170435
Methodology: https://510kreport.com/methodology