510(k) · Cleared
Recalled · 2026Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
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 Aug 23, 2024 as substantially equivalent to K221376 (Boston Scientific Neuromodulation, 2022) after a 268-day review. Its family tree reaches back 10 generations to 1988. It has been recalled once.
- Decided
- Aug 23, 2024
- Review
- 268 days
- Class
- Class II
- Product code
- GZB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 10 generations to K883780 (1988). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK883780 Xtrel, Model Number 3425Medtronic Vascular · 1988
- 6 generations between
- 3 generations backK201618 Nalu Neurostimulation SCS systemBoston Scientific Neuromodulation · 2020
- 2 generations backK203547 Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2021
- 1 generation backK221376 Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2022
- This deviceK233801 Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu…Boston Scientific Neuromodulation · 2024
Show all 10 generations
- Root · 10 generations backK883780 Xtrel, Model Number 3425Medtronic Vascular · 1988
- 9 generations backK141399 Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated · 2014
- 8 generations backK150517 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2015
- 7 generations backK160600 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2016
- 6 generations backK162161 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2016
- 5 generations backK170141 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2017
- 4 generations backK183047 Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2019 · Recalled
- 3 generations backK201618 Nalu Neurostimulation SCS systemBoston Scientific Neuromodulation · 2020
- 2 generations backK203547 Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2021
- 1 generation backK221376 Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2022
- This deviceK233801 Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu…Boston Scientific Neuromodulation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K883780 | Xtrel, Model Number 3425 | Medtronic Vascular | 1988 | — |
| −9 | K141399 | Freedom Spinal Cord Stimulator (SCS) System | Stimwave Technologies Incorporated | 2014 | — |
| −8 | K150517 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2015 | — |
| −7 | K160600 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2016 | — |
| −6 | K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable… | Stimwave Technologies Incorporated | 2016 | — |
| −5 | K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable… | Stimwave Technologies Incorporated | 2017 | — |
| −4 | K183047 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2019 | 1 |
| −3 | K201618 | Nalu Neurostimulation SCS system | Boston Scientific Neuromodulation | 2020 | — |
| −2 | K203547 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2021 | — |
| −1 | K221376 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2022 | — |
| 0 (this device) | K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu… | Boston Scientific Neuromodulation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 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 K221376 Nalu Neurostimulation Systemscore 8.9 · 9 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 |
|---|---|---|---|
| * | K221376 | Nalu Neurostimulation SystemSummary page 5…Class II Review Panel Neurology Predicate/Reference Devices • Predicate Device: Nalu Neurostimulation System (for SCS & PNS) (K221376) • Reference Device: Nalu Neurostimulation System for SCS (K202274) • Reference Device: Nalu Neurostimulation Syste… | 2022 |
| † | K202274 | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit… | 2020 |
| † | K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 30, 2026 | Not classified | Z-0311-2027 | Software change control | Therapy Disc (TD) that powers and sends stimulation signals to an Implantable Pulse Generator (IPG), part of a neurostimulation system, has a firmware issue that causes the TD to attempt to restart, then fail, leading it to become… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 12 ancestors has a recall of any class.
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. 2024, 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?
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. PNS: This system is indicated for pain management in adults…
Read the full statement (143 words)
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.
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 Nalu Neurostimulation System for PNS 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 as stated in the FDA summary.
https://510kreport.com/device/K233801 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233801: Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233801
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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