# K250451: NeurAxis IB-Stim (01-1020)

- Pathway: 510(k) (Traditional)
- Applicant: Neuraxis
- Decided: May 15, 2025 after 86 days
- Product code: QHH (Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs))
- Device class: 2
- Regulation: 21 CFR 876.5340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN180057 (2019). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241533: NeurAxis IB-Stim (01-1020), Neuraxis (2024) Summary page 5.

## Most influential descendants
- K252024: NeurAxis IB-Stim (01-1020) (2025), 0 descendants of its own

## Indications for use
The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 8-21 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS) and functional dyspepsia (FD). The IB-Stim is intended to be used for 120 hours per week, using 1 device per week for 4 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS and FD. FD patients for whom IB-Stim is indicated have also been shown to experience reduction of nausea symptoms.

Source page: https://510kreport.com/device/K250451
Methodology: https://510kreport.com/methodology