510(k) · Cleared
ClearedPeripheral Nerve Stimulation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Cleared on Nov 10, 1998 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 15 later devices descend from it.
- Decided
- Nov 10, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- GZF
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK982902 Peripheral Nerve StimulationMedtronic Vascular · 1998
- Descendant · cites it directly · 14 of its ownK011702 Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100…Vertis Neuroscience, Inc. · 2001
- Descendant · 2 generations on · 13 of its ownK022241 Vertis PNT Control Unit, Model CU 100; Vertis PNT…Vertis Neuroscience, Inc. · 2002
- Descendant · 3 generations on · 12 of its ownK061166 Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 2006
- Descendant · 4 generations on · 11 of its ownK072123 Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008
- Descendant · 4 generations on · 9 of its ownK161154 Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator…Spr Therapeutics, LLC · 2016
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K011702Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, SgxxxVertis Neuroscience, Inc. · 2001 · cites it directly14descendants
- K022241Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXXVertis Neuroscience, Inc. · 2002 · 2 generations on13descendants
- K061166Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 2006 · 3 generations on12descendants
- K072123Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008 · 4 generations on11descendants
- K161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…Spr Therapeutics, LLC · 2016 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982902 | Peripheral Nerve Stimulation | Medtronic Vascular | 1998 | — |
| +1 | K011702 | Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx | Vertis Neuroscience, Inc. | 2001 | — |
| +2 | K022241 | Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG… | Vertis Neuroscience, Inc. | 2002 | — |
| +3 | K061166 | Deepwave Percutaneous Neuromodulation Pain Therapy System | Biowave Corporation | 2006 | — |
| +4 | K072123 | Homewave Neuromodulations Pain Therapy Device | Biowave Corporation | 2008 | — |
| +4 | K161154 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and… | Spr Therapeutics, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011702 | Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx | 2001 | 14 |
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?
- Of its descendants, K011702 (Vertis Neuroscience, Inc., 2001) has gone furthest, with 14 descendants of its own.
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.
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?
Peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.
In order to maintain consistency between products, this indication will be used for all Medtronic PNS indicated devices.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982902 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982902: Peripheral Nerve Stimulation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982902
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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