# K252024: NeurAxis IB-Stim (01-1020)

- Pathway: 510(k) (Traditional)
- Applicant: Neuraxis
- Decided: Oct 16, 2025 after 108 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: 3 generations back to DEN180057 (2019). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250451: NeurAxis IB-Stim (01-1020), Neuraxis (2025) Summary page 5.

## Indications for use
The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 8 years and older 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/K252024
Methodology: https://510kreport.com/methodology