# GZF: Stimulator, Peripheral Nerve, Implanted (Pain Relief)

- Device class: 2; regulation: 21 CFR 882.5870; FDA's rule: 510(k) required
- FDA decisions: 26
- 510(k) review time 2021–2025: median 267 days (middle half 232–340)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 1
- 2017: 1
- 2019: 3
- 2020: 2
- 2021: 1
- 2022: 1
- 2023: 1
- 2024: 2
- 2025: 2
- 2026: 2

## Most-cited predicates
- K183579: Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits (2019), cited by 5
- K000852: Renew Neurostimulation System (2001), cited by 4
- K171366: Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit (2017), cited by 3
- K211965: StimRouter Neuromodulation System (2022), cited by 2
- K200482: StimRouter Neuromodulation System (2020), cited by 1
- K904409: Medtronic (R) Model 3470 X-Trel (TM) Receiver (1991), cited by 1
- K915540: Model 3587A Resume II Lead (1992), cited by 1
- K190047: StimRouter Neuromodulation System (2019), cited by 1
- K152178: StimQ Peripheral Nerve Stimulator (PNS) System (2016), cited by 1
- K142432: StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit (2015), cited by 1

Source page: https://510kreport.com/product-code/GZF
Data by year (CSV): https://510kreport.com/product-code/GZF.csv