510(k) · Cleared
ClearedPolyether Urethane Material Change in Neurostimulation Leads
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 Mar 25, 2004 as substantially equivalent to K923931 (Medtronic Vascular, 1993) and 7 other predicates after a 21-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Mar 25, 2004
- Review
- 21 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 2 generations to K905407 (1991). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK905407 Model 3487A Pisces-Quad,3587A Resume,3586 ResumeMedtronic Vascular · 1991
- 1 generation backK032561 Resume II Lead Kit for Spinal Cord Stimulation (SCS) and Peripheral…Medtronic Vascular · 2003
- This deviceK040568 Polyether Urethane Material Change in Neurostimulation LeadsMedtronic Vascular · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905407 | Model 3487A Pisces-Quad,3587A Resume,3586 Resume | Medtronic Vascular | 1991 | — |
| −1 | K032561 | Resume II Lead Kit for Spinal Cord Stimulation (SCS) and Peripheral Nerve… | Medtronic Vascular | 2003 | — |
| 0 (this device) | K040568 | Polyether Urethane Material Change in Neurostimulation Leads | Medtronic Vascular | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 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? (8)
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 |
|---|---|---|---|
| * | K923931 | Medtronic Model 3487A Pisces-Quad LeadSummary page 2…Classification Code: GZB-Spinal Cord Stimulators GZF-Peripheral Nerve Stimulators Predicate Device: Pisces Quad 3487A-K923931 Pisces Quad Compact 3887-K923931 Pisces Quad Plus 3888-K923567… | 1993 |
| * | K923567 | Medtronic Model 3888 Pisces-Quad Plus LeadSummary page 2…Stimulators Predicate Device: Pisces Quad 3487A-K923931 Pisces Quad Compact 3887-K923931 Pisces Quad Plus 3888-K923567 Pisces Z Quad 3890-K033016 Pisces Z Quad Compact 3891-K033016… | 1992 |
| * | K033016 | Pisces Z Quad Lead Model, 3890, Pisces Z Quad Compact Lead Model, 3891, Pisces Z Quad…Summary page 2…487A-K923931 Pisces Quad Compact 3887-K923931 Pisces Quad Plus 3888-K923567 Pisces Z Quad 3890-K033016 Pisces Z Quad Compact 3891-K033016 Pisces Z Quad Plus 3892-K033016… | 2003 |
| * | K971756 | Medtronic Model 3998 LeadSummary page 2…d 3890-K033016 Pisces Z Quad Compact 3891-K033016 Pisces Z Quad Plus 3892-K033016 Specify 3998-K971756 Pisces Octad 3898-K934065 Resume II 3587A-K032561 SymM… | 1998 |
| * | K934065 | Medtronic Mattrix 3271/3272 Neurostimulation SystemSummary page 2…ad Compact 3891-K033016 Pisces Z Quad Plus 3892-K033016 Specify 3998-K971756 Pisces Octad 3898-K934065 Resume II 3587A-K032561 SymMix 3982A-K032561 Resume TL… | 1995 |
| * | K032561 | Resume II Lead Kit for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation…Summary page 2…Pisces Z Quad Plus 3892-K033016 Specify 3998-K971756 Pisces Octad 3898-K934065 Resume II 3587A-K032561 SymMix 3982A-K032561 Resume TL 3986A-K032561 On-Point… | 2003 |
| * | K912764 | Medtronic Model 3861 Temporary Screening Lead KitSummary page 2…x 3982A-K032561 Resume TL 3986A-K032561 On-Point 3987A-K032561 Temporary Screening Lead 386 l--K912764 Verify 3862-K932202 Device Description: Resume II 3587A, Resume TL 3986A, On-Point 3987A, and… | 1991 |
| * | K932202 | Model 3862A & B 3863A & B Temp. Lead Screening KitSummary page 2…me TL 3986A-K032561 On-Point 3987A-K032561 Temporary Screening Lead 386 l--K912764 Verify 3862-K932202 Device Description: Resume II 3587A, Resume TL 3986A, On-Point 3987A, and SymMix 3982A are quadrip… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 1 company; a new generation was cleared every 12.6 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 2 other devices also cite its predicate K923931.
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?
Pisces Quad Model 3487A, Pisces Quad Compact Model 3887, Pisces Quad Plus Model 3888, Pisces Z Quad Model 3890, Pisces Z Quad Compact Model 3891, Pisces Z Quad Plus Model 3892, Specify Model 3998, Pisces Octad Model 3898, SymMix Model 3982A, Temporary Screening Lead Model 3861, and Verify Model 3862 are indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs. Resume II Model 3587A and Resume TL…
Read the full statement (154 words)
Pisces Quad Model 3487A, Pisces Quad Compact Model 3887, Pisces Quad Plus Model 3888, Pisces Z Quad Model 3890, Pisces Z Quad Compact Model 3891, Pisces Z Quad Plus Model 3892, Specify Model 3998, Pisces Octad Model 3898, SymMix Model 3982A, Temporary Screening Lead Model 3861, and Verify Model 3862 are indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs.
Resume II 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040568 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040568: Polyether Urethane Material Change in Neurostimulation Leads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040568
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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