510(k) · Cleared
ClearedNeurAxis IB-Stim (01-1020)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuraxis · QHH Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
Cleared on Oct 16, 2025 as substantially equivalent to K250451 (Neuraxis, 2025) after a 108-day review. Its family tree reaches back 3 generations to 2019.
- Decided
- Oct 16, 2025
- Review
- 108 days
- Class
- Class II
- Product code
- QHH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN180057 (2019). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QHH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QHH device
- #1 K250451 NeurAxis IB-Stim (01-1020)score 12.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K250451 | NeurAxis IB-Stim (01-1020)Summary page 5…Panel: Neurology Product Code: QHH Primary Predicate: NeurAxis IB-Stim (K250451) Device Description: IB-Stim stimulator is a battery-operated micro-stimulation appliance weighing 5 grams designed as a dispo… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All QHH devicesQHH Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QHH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QHH
Too few QHH 510(k)s in any year since 2007 to give a median.
Recalls per year · QHH
No recall names QHH since 2007.
Adverse event reports per year · QHH
2in 2023
MAUDE reports naming product code QHH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252024: NeurAxis IB-Stim (01-1020).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252024
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026