510(k) · Cleared
ClearedReceiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stimwave Technologies Incorporated · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Cleared on Dec 16, 2016 as substantially equivalent to K160600 (Stimwave Technologies Incorporated, 2016) and 2 other predicates after a 136-day review. Its family tree reaches back 4 generations to 1988. 20 later devices descend from it.
- Decided
- Dec 16, 2016
- Review
- 136 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K883780 (1988). 6 ancestors in all. 20 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK883780 Xtrel, Model Number 3425Medtronic Vascular · 1988
- 3 generations backK141399 Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated · 2014
- 2 generations backK150517 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2015
- 1 generation backK160600 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2016
- This deviceK162161 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2016
- Descendant · cites it directly · 19 of its ownK170141 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2017
- Descendant · 2 generations on · 9 of its ownK171366 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG…Stimwave Technologies Inc., Dba Stimq, LLC · 2017 · Recalled
- Descendant · 3 generations on · 6 of its ownK183579 Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu…Boston Scientific Neuromodulation · 2019 · Recalled
- Descendant · 2 generations on · 6 of its ownK183047 Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2019 · Recalled
- Descendant · 3 generations on · 3 of its ownK201618 Nalu Neurostimulation SCS systemBoston Scientific Neuromodulation · 2020
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly…Stimwave Technologies Incorporated · 2017 · cites it directly19descendants
- K171366Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory…Stimwave Technologies Inc., Dba Stimq, LLC · 2017 · 2 generations on9descendants
- K183579Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation…Boston Scientific Neuromodulation · 2019 · 3 generations on6descendants
- K183047Nalu Neurostimulation SystemBoston Scientific Neuromodulation · 2019 · 2 generations on6descendants
- K201618Nalu Neurostimulation SCS systemBoston Scientific Neuromodulation · 2020 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K883780 | Xtrel, Model Number 3425 | Medtronic Vascular | 1988 | — |
| −3 | K141399 | Freedom Spinal Cord Stimulator (SCS) System | Stimwave Technologies Incorporated | 2014 | — |
| −2 | K150517 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2015 | — |
| −1 | K160600 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2016 | — |
| 0 (this device) | K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable… | Stimwave Technologies Incorporated | 2016 | — |
| +1 | K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable… | Stimwave Technologies Incorporated | 2017 | — |
| +2 | K171366 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG… | Stimwave Technologies Inc., Dba Stimq, LLC | 2017 | 6 |
| +3 | K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu… | Boston Scientific Neuromodulation | 2019 | 1 |
| +2 | K183047 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2019 | 1 |
| +3 | K201618 | Nalu Neurostimulation SCS system | Boston Scientific Neuromodulation | 2020 | — |
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 |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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 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? (3)
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 |
|---|---|---|---|
| * | K160600 | Freedom Spinal Cord Stimulator System Cleared while this submission was under review Summary page 4…evice Class: Class II Classification Panel: Neurology 4. Legally Marketed Predicate Device(s) Stimwave Freedom SCS System FR8A/FR4A, LBRD-915-2A (K160600) Stimwave Freedom SCS System FR8A/FR4A, LBRD-915-2A (K150517) Stimwave Freedom SCS System FRE4-A001, FRT4-A001, WAA-A012 (K141399… | 2016 |
| * | K150517 | Freedom Spinal Cord Stimulator SystemSummary page 4…Neurology 4. Legally Marketed Predicate Device(s) Stimwave Freedom SCS System FR8A/FR4A, LBRD-915-2A (K160600) Stimwave Freedom SCS System FR8A/FR4A, LBRD-915-2A (K150517) Stimwave Freedom SCS System FRE4-A001, FRT4-A001, WAA-A012 (K141399) 5. Device Description This submission is based upon the e… | 2015 |
| * | K141399 | Freedom Spinal Cord Stimulator (SCS) SystemSummary page 4…edom SCS System FR8A/FR4A, LBRD-915-2A (K160600) Stimwave Freedom SCS System FR8A/FR4A, LBRD-915-2A (K150517) Stimwave Freedom SCS System FRE4-A001, FRT4-A001, WAA-A012 (K141399) 5. Device Description This submission is based upon the established Stimwave product family offering additional surgical kitti… | 2014 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly… | 2017 | 19 |
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 28 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K170141 (Stimwave Technologies Incorporated, 2017) has gone furthest, with 19 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. 2016, 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?
The Freedom Spinal Cord Stimulator (SCS) System is intended 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 lower limbs, including unilateral or bilateral pain. The Freedom-8A Trial Lead Kit is only used in conjunction with the Freedom-8A Stimulator Receiver Kit, and the Freedom-4A Trial Lead Kit is used for either the Receiver Kit Freedom-4A Stimulator or the Receiver Kit Freedom-8A Stimulator. 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/K162161 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162161: Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162161
Report an extraction error
Are you the manufacturer?
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