De Novo · Granted
GrantedIB-Stim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Health Solutions (Ihs), Inc. · QHH Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
Granted on Jun 7, 2019 as a new device type through De Novo after a 225-day review. 5 later devices descend from it.
- Decided
- Jun 7, 2019
- Review
- 225 days
- Class
- Class II
- Product code
- QHH
- Recalls
- None
5 later devices descend from it, 3 citing it directly.
- This deviceDEN180057 IB-StimInnovative Health Solutions (Ihs), Inc. · 2019
- Descendant · cites it directly · 2 of its ownK241533 NeurAxis IB-Stim (01-1020)Neuraxis · 2024
- Descendant · 2 generations on · 1 of its ownK250451 NeurAxis IB-Stim (01-1020)Neuraxis · 2025
- Descendant · 3 generations on · 0 of its ownK252024 NeurAxis IB-Stim (01-1020)Neuraxis · 2025
- Descendant · cites it directly · 0 of its ownK230526 TEA DeviceTranstimulation Research, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK202940 First Relief v1Dyansys, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K241533NeurAxis IB-Stim (01-1020)Neuraxis · 2024 · cites it directly2descendants
- K250451NeurAxis IB-Stim (01-1020)Neuraxis · 2025 · 2 generations on1descendant
- K252024NeurAxis IB-Stim (01-1020)Neuraxis · 2025 · 3 generations on0descendants
- K230526TEA DeviceTranstimulation Research, Inc. · 2023 · cites it directly0descendants
- K202940First Relief v1Dyansys, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180057 | IB-Stim | Innovative Health Solutions (Ihs), Inc. | 2019 | — |
| +1 | K241533 | NeurAxis IB-Stim (01-1020) | Neuraxis | 2024 | — |
| +2 | K250451 | NeurAxis IB-Stim (01-1020) | Neuraxis | 2025 | — |
| +3 | K252024 | NeurAxis IB-Stim (01-1020) | Neuraxis | 2025 | — |
| +1 | K230526 | TEA Device | Transtimulation Research, Inc. | 2023 | — |
| +1 | K202940 | First Relief v1 | Dyansys, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K241533 (Neuraxis, 2024) has gone furthest, with 2 descendants of its own.
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. 2019, 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 11-18 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 up to 3 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180057 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180057: IB-Stim.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180057
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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