510(k) · Cleared
Recalled · Class II · 2024Nalu 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
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Neuromodulation · GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Cleared on Mar 29, 2019 as substantially equivalent to K171366 (Stimwave Technologies Inc., Dba Stimq, LLC, 2017) after a 98-day review. Its family tree reaches back 7 generations to 1988. 6 later devices descend from it. It has been recalled once.
- Decided
- Mar 29, 2019
- Review
- 98 days
- Class
- Class II
- Product code
- GZF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K883780 (1988). 10 ancestors in all. 6 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK883780 Xtrel, Model Number 3425Medtronic Vascular · 1988
- 6 generations backK141399 Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated · 2014
- 5 generations backK150517 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2015
- 4 generations backK160600 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2016
- 3 generations backK162161 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2016
- 2 generations backK170141 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2017
- 1 generation backK171366 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG…Stimwave Technologies Inc., Dba Stimq, LLC · 2017 · Recalled
- This deviceK183579 Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu…Boston Scientific Neuromodulation · 2019
- Descendant · cites it directly · 1 of its ownK202781 Neuspera Neurostimulation System (NNS)Neuspera Medical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK243782 StimTrial Neuromodulation SystemBioventus, LLC · 2025
- Descendant · cites it directly · 0 of its ownK243678 TalisMann Neuromodulation SystemBioventus, LLC · 2025
- Descendant · cites it directly · 0 of its ownK232415 Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation · 2024
- Descendant · 2 generations on · 0 of its ownK221303 Neuspera Nuity SystemNeuspera Medical, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K202781Neuspera Neurostimulation System (NNS)Neuspera Medical, Inc. · 2021 · cites it directly1descendant
- K243782StimTrial Neuromodulation SystemBioventus, LLC · 2025 · cites it directly0descendants
- K243678TalisMann Neuromodulation SystemBioventus, LLC · 2025 · cites it directly0descendants
- K232415Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation · 2024 · cites it directly0descendants
- K221303Neuspera Nuity SystemNeuspera Medical, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K883780 | Xtrel, Model Number 3425 | Medtronic Vascular | 1988 | — |
| −6 | K141399 | Freedom Spinal Cord Stimulator (SCS) System | Stimwave Technologies Incorporated | 2014 | — |
| −5 | K150517 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2015 | — |
| −4 | K160600 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2016 | — |
| −3 | K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable… | Stimwave Technologies Incorporated | 2016 | — |
| −2 | K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable… | Stimwave Technologies Incorporated | 2017 | — |
| −1 | K171366 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG… | Stimwave Technologies Inc., Dba Stimq, LLC | 2017 | 6 |
| 0 (this device) | K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu… | Boston Scientific Neuromodulation | 2019 | — |
| +1 | K202781 | Neuspera Neurostimulation System (NNS) | Neuspera Medical, Inc. | 2021 | — |
| +1 | K243782 | StimTrial Neuromodulation System | Bioventus, LLC | 2025 | — |
| +1 | K243678 | TalisMann Neuromodulation System | Bioventus, LLC | 2025 | — |
| +1 | K232415 | Nalu Neurostimulation System for Peripheral Nerve Stimulation | Boston Scientific Neuromodulation | 2024 | — |
| +2 | K221303 | Neuspera Nuity System | Neuspera Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K171366 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory…Summary page 4…ef) Class: Class II Device Classification Panel: Neurology 5.4. Legally Marketed Predicate Device(s) StimQ Peripheral Nerve Stimulator (PNS) System (K171366) by StimQ LLC Hereafter, also referred to as the StimQ PNS System or StimQ For areas where slight differences occur between the… | 2017 |
| † | K152178 | StimQ Peripheral Nerve Stimulator (PNS) System | 2016 |
| † | K150517 | Freedom Spinal Cord Stimulator System | 2015 |
| † | K934065 | Medtronic Mattrix 3271/3272 Neurostimulation System | 1995 |
| † | K883780 | Xtrel, Model Number 3425 | 1988 |
| † | K000852 | Renew Neurostimulation System | 2001 |
| † | K141399 | Freedom Spinal Cord Stimulator (SCS) System | 2014 |
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202781 | Neuspera Neurostimulation System (NNS) | 2021 | 1 |
| K243782 | StimTrial Neuromodulation System | 2025 | 0 |
| K243678 | TalisMann Neuromodulation System | 2025 | 0 |
| K232415 | Nalu Neurostimulation System for Peripheral Nerve Stimulation | 2024 | 0 |
| K191435 | IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4… | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 3, 2024 | Class II | Z-2257-2024 | Nonconforming Material/Component | Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K202781 (Neuspera Medical, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K171366.
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?
This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region.
The trial devices are solely used for trial stimulation (no longer thank 30 days) to determine efficacy before recommendation for a permanent (long term) device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183579 · printed Nov 4, 2026
Cite this page
510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183579
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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