510(k) · Cleared
ClearedNalu Neurostimulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Neuromodulation · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Cleared on Jun 10, 2022 as substantially equivalent to K203547 (Boston Scientific Neuromodulation, 2021) after a 29-day review. Its family tree reaches back 9 generations to 1988. 1 later device descends from it.
- Decided
- Jun 10, 2022
- Review
- 29 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K883780 (1988). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK883780 Xtrel, Model Number 3425Medtronic Vascular · 1988
- 5 generations between
- 3 generations backK183047 Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2019 · Recalled
- 2 generations backK201618 Nalu Neurostimulation SCS systemBoston Scientific Neuromodulation · 2020
- 1 generation backK203547 Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2021
- This deviceK221376 Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2022
- Descendant · cites it directly · 0 of its ownK233801 Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu…Boston Scientific Neuromodulation · 2024 · Recalled
Show all 9 generations
- Root · 9 generations backK883780 Xtrel, Model Number 3425Medtronic Vascular · 1988
- 8 generations backK141399 Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated · 2014
- 7 generations backK150517 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2015
- 6 generations backK160600 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2016
- 5 generations backK162161 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2016
- 4 generations backK170141 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2017
- 3 generations backK183047 Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2019 · Recalled
- 2 generations backK201618 Nalu Neurostimulation SCS systemBoston Scientific Neuromodulation · 2020
- 1 generation backK203547 Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2021
- This deviceK221376 Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2022
Most influential descendants
Showing 1 of 1 · See all- K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System…Boston Scientific Neuromodulation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K883780 | Xtrel, Model Number 3425 | Medtronic Vascular | 1988 | — |
| −8 | K141399 | Freedom Spinal Cord Stimulator (SCS) System | Stimwave Technologies Incorporated | 2014 | — |
| −7 | K150517 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2015 | — |
| −6 | K160600 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2016 | — |
| −5 | K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable… | Stimwave Technologies Incorporated | 2016 | — |
| −4 | K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable… | Stimwave Technologies Incorporated | 2017 | — |
| −3 | K183047 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2019 | 1 |
| −2 | K201618 | Nalu Neurostimulation SCS system | Boston Scientific Neuromodulation | 2020 | — |
| −1 | K203547 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2021 | — |
| 0 (this device) | K221376 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2022 | — |
| +1 | K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu… | Boston Scientific Neuromodulation | 2024 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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 GZB? 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 GZB device
- #1 K233801 Nalu Neurostimulation System for Spinal Cord…score 8.6 · 10 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 |
|---|---|---|---|
| * | K203547 | Nalu Neurostimulation SystemSummary page 4…or for pain relief Product Code GZF Review Panel Division of Neurology 4. Predicate Device(s) Nalu Neurostimulation System, K203547 For software differences between the Nalu Neuromodulation System and the predicate(s) (K203547), substantial equiv… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System… | 2024 | 0 |
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?
- The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K233801 (Boston Scientific Neuromodulation, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GZB devicesGZB Stimulator, Spinal-Cord, Implanted (Pain Relief): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · GZB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GZB
149in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZB
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZB
313in 2025
MAUDE reports naming product code GZB, 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 | 2 | — | 0 | 201 |
| 2008 | 1 | — | 1 | 68 |
| 2009 | 3 | 62 | 0 | 59 |
| 2010 | 1 | — | 1 | 157 |
| 2011 | 4 | 67 | 0 | 471 |
| 2012 | 2 | — | 0 | 1,090 |
| 2013 | 2 | — | 0 | 4,428 |
| 2014 | 2 | — | 0 | 10,849 |
| 2015 | 2 | — | 0 | 7,507 |
| 2016 | 2 | — | 0 | 4,556 |
| 2017 | 2 | — | 0 | 5,511 |
| 2018 | 1 | — | 0 | 5,244 |
| 2019 | 4 | 149 | 0 | 643 |
| 2020 | 2 | — | 0 | 466 |
| 2021 | 1 | — | 0 | 332 |
| 2022 | 1 | — | 0 | 209 |
| 2023 | 0 | — | 0 | 236 |
| 2024 | 1 | — | 0 | 318 |
| 2025 | 0 | — | 0 | 313 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Spinal Cord Stimulation (SCS) This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device. Peripheral Nerve Stimulation (PNS)…
Read the full statement (145 words)
Spinal Cord Stimulation (SCS)
This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.
The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
Peripheral Nerve Stimulation (PNS)
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 than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
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/K221376 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221376: Nalu Neurostimulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221376
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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