510(k) · Cleared
ClearedResume II Lead Kit for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS), Resume TL Lead Kit for
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Cleared on Sep 11, 2003 as substantially equivalent to K905407 (Medtronic Vascular, 1991) and 2 other predicates after a 22-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Sep 11, 2003
- Review
- 22 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K905407 (1991). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK905407 Model 3487A Pisces-Quad,3587A Resume,3586 ResumeMedtronic Vascular · 1991
- This deviceK032561 Resume II Lead Kit for Spinal Cord Stimulation (SCS) and Peripheral…Medtronic Vascular · 2003
- Descendant · cites it directly · 0 of its ownK040568 Polyether Urethane Material Change in Neurostimulation LeadsMedtronic Vascular · 2004
Most influential descendants
Showing 1 of 1 · See all- K040568Polyether Urethane Material Change in Neurostimulation LeadsMedtronic Vascular · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905407 | Model 3487A Pisces-Quad,3587A Resume,3586 Resume | Medtronic Vascular | 1991 | — |
| 0 (this device) | K032561 | Resume II Lead Kit for Spinal Cord Stimulation (SCS) and Peripheral Nerve… | Medtronic Vascular | 2003 | — |
| +1 | K040568 | Polyether Urethane Material Change in Neurostimulation Leads | Medtronic Vascular | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (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 |
|---|---|---|---|
| * | K905407 | Model 3487A Pisces-Quad,3587A Resume,3586 Resume Our reading of the summary gave K904507, FDA’s number for Pilling Brush Valvulotome (Pilling Co.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Resume I1 3587A”. | 1991 |
| * | K913993 | Medtronic Models 3982 a,B,C&D Stag Array Res LeadsSummary page 1…dicate Device: Resume I1 3587A - K904507 Resume TL 3986 - K904507 SymMix 3982 - K913993 On-Point - K920567 Device Description: Quadripolar implantable neurostimulat… | 1992 |
| * | K920567 | Models 3987 and 3988 Resume Lead for PNSSummary page 1…507 Resume TL 3986 - K904507 SymMix 3982 - K913993 On-Point - K920567 Device Description: Quadripolar implantable neurostimulation surgical leads… | 1992 |
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 |
|---|---|---|---|
| K040568 | Polyether Urethane Material Change in Neurostimulation Leads | 2004 | 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?
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.
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?
Resume 11 Model 3587A and Resume TL Model 3986A are indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs. They are also indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain. On-Point Model 3987A is indicated for Peripheral Nerve Stimulation. The peripheral nerve…
Read the full statement (107 words)
Resume 11 Model 3587A and Resume TL Model 3986A are indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs. They are also indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.
On-Point Model 3987A is indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.
SymMix Model 3982A is indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032561: Resume II Lead Kit for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS), Resume TL Lead Kit for.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032561
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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