# K142432: StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit

- Pathway: 510(k) (Traditional)
- Applicant: Bioness, Inc.
- Decided: Feb 20, 2015 after 175 days
- Product code: GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K190047: StimRouter Neuromodulation System (2019), 4 descendants of its own
- K200482: StimRouter Neuromodulation System (2020), 3 descendants of its own
- K211965: StimRouter Neuromodulation System (2022), 2 descendants of its own
- K243782: StimTrial Neuromodulation System (2025), 0 descendants of its own
- K243678: TalisMann Neuromodulation System (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K142432
Methodology: https://510kreport.com/methodology