510(k) · Cleared
ClearedStimRouter Neuromodulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioness, Inc. · GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Cleared on Oct 31, 2019 as substantially equivalent to K142432 (Bioness, Inc., 2015) after a 295-day review. Its family tree reaches back 1 generation to 2015. 4 later devices descend from it.
- Decided
- Oct 31, 2019
- Review
- 295 days
- Class
- Class II
- Product code
- GZF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K142432 (2015). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK142432 StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter…Bioness, Inc. · 2015
- This deviceK190047 StimRouter Neuromodulation SystemBioness, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK200482 StimRouter Neuromodulation SystemBioness, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK211965 StimRouter Neuromodulation SystemBioness, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK243782 StimTrial Neuromodulation SystemBioventus, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK243678 TalisMann Neuromodulation SystemBioventus, LLC · 2025
Most influential descendants
Showing 4 of 4 · See all- K200482StimRouter Neuromodulation SystemBioness, Inc. · 2020 · cites it directly3descendants
- K211965StimRouter Neuromodulation SystemBioness, Inc. · 2022 · 2 generations on2descendants
- K243782StimTrial Neuromodulation SystemBioventus, LLC · 2025 · 3 generations on0descendants
- K243678TalisMann Neuromodulation SystemBioventus, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K142432 | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician… | Bioness, Inc. | 2015 | — |
| 0 (this device) | K190047 | StimRouter Neuromodulation System | Bioness, Inc. | 2019 | — |
| +1 | K200482 | StimRouter Neuromodulation System | Bioness, Inc. | 2020 | — |
| +2 | K211965 | StimRouter Neuromodulation System | Bioness, Inc. | 2022 | — |
| +3 | K243782 | StimTrial Neuromodulation System | Bioventus, LLC | 2025 | — |
| +3 | K243678 | TalisMann Neuromodulation System | Bioventus, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 GZF? 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 GZF device
- #1 K243782 StimTrial Neuromodulation Systemscore 11.8 · 8 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 |
|---|---|---|---|
| * | K142432 | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter…Summary page 4…dicate Device Predicate Manufacturer: Bioness Inc. Predicate Trade Name: StimRouter Neuromodulation System Predicate 510(k): K142432 Reference Devices: 30 September 2019 2 ===… | 2015 |
| † | K904409 | Medtronic (R) Model 3470 X-Trel (TM) Receiver | 1991 |
| † | K920567 | Models 3987 and 3988 Resume Lead for PNS | 1992 |
| † | K982902 | Peripheral Nerve Stimulation | 1998 |
| † | K000582 | Freestyle Blood Glucose Monitoring System, Cat NO 11001 | 2000 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200482 | StimRouter Neuromodulation System | 2020 | 3 |
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?
- Its one ancestor has no recall.
- Of its descendants, K200482 (Bioness, Inc., 2020) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GZF devicesGZF Stimulator, Peripheral Nerve, Implanted (Pain Relief): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GZF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZF
99in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZF
No recall names GZF since 2007.
Adverse event reports per year · GZF
597in 2025
MAUDE reports naming product code GZF, 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 | 7 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 0 | — | 0 | 12 |
| 2013 | 0 | — | 0 | 77 |
| 2014 | 0 | — | 0 | 268 |
| 2015 | 1 | — | 0 | 346 |
| 2016 | 1 | — | 0 | 414 |
| 2017 | 1 | — | 0 | 330 |
| 2018 | 0 | — | 0 | 318 |
| 2019 | 3 | 99 | 0 | 64 |
| 2020 | 2 | — | 0 | 104 |
| 2021 | 1 | — | 0 | 226 |
| 2022 | 1 | — | 0 | 183 |
| 2023 | 1 | — | 0 | 524 |
| 2024 | 2 | — | 0 | 678 |
| 2025 | 2 | — | 0 | 597 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.
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/K190047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190047: StimRouter Neuromodulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190047
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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