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 30, 2024 as substantially equivalent to DEN180057 (Innovative Health Solutions (Ihs), Inc., 2019) after a 153-day review. Its family tree reaches back 1 generation to 2019. 2 later devices descend from it.
- Decided
- Oct 30, 2024
- Review
- 153 days
- Class
- Class II
- Product code
- QHH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180057 (2019). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN180057 IB-StimInnovative Health Solutions (Ihs), Inc. · 2019
- This deviceK241533 NeurAxis IB-Stim (01-1020)Neuraxis · 2024
- Descendant · cites it directly · 1 of its ownK250451 NeurAxis IB-Stim (01-1020)Neuraxis · 2025
- Descendant · 2 generations on · 0 of its ownK252024 NeurAxis IB-Stim (01-1020)Neuraxis · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180057 | IB-Stim | Innovative Health Solutions (Ihs), Inc. | 2019 | — |
| 0 (this device) | K241533 | NeurAxis IB-Stim (01-1020) | Neuraxis | 2024 | — |
| +1 | K250451 | NeurAxis IB-Stim (01-1020) | Neuraxis | 2025 | — |
| +2 | K252024 | NeurAxis IB-Stim (01-1020) | Neuraxis | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
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 12.7 · 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 |
|---|---|---|---|
| * | DEN180057 | IB-StimSummary page 6…d with other therapies for IBS. Substantial Equivalence: The subject NeurAxis IB-Stim is substantially equivalent to the predicate device, NeurAxis, Inc. IB-Stim – DEN180057. The design, materials, packaging, sterilization, and package label of the subject device are identical to those of the predic… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250451 | NeurAxis IB-Stim (01-1020) | 2025 | 1 |
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?
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. 2024, 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 8-21 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). 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, VI, 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241533 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241533: NeurAxis IB-Stim (01-1020).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241533
Report an extraction error
Are you the manufacturer?
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