510(k) · Cleared
ClearedPisces Z Quad Lead Model, 3890, Pisces Z Quad Compact Lead Model, 3891, Pisces Z Quad Plus Lead Model, 3892
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Neurological · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Cleared on Oct 30, 2003 as substantially equivalent to K923931 (Medtronic Vascular, 1993) and 1 other predicate after a 34-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Oct 30, 2003
- Review
- 34 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923567 (1992). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK923567 Medtronic Model 3888 Pisces-Quad Plus LeadMedtronic Vascular · 1992
- This deviceK033016 Pisces Z Quad Lead Model, 3890, Pisces Z Quad Compact Lead Model…Medtronic Neurological · 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 | K923567 | Medtronic Model 3888 Pisces-Quad Plus Lead | Medtronic Vascular | 1992 | — |
| 0 (this device) | K033016 | Pisces Z Quad Lead Model, 3890, Pisces Z Quad Compact Lead Model, 3891, Pisces… | Medtronic Neurological | 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 |
|---|---|---|
| 1993 | 1 | 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? (2)
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 1…Pisces Z Quad Plus Model 3892 Lead B. Name of Predicate Devices Medtronic Neurological Models 3487A and 3887 Leads K923931 Medtronic Neurological Model 3888 Lead K923567 C. Device Description The funct… | 1993 |
| * | K923567 | Medtronic Model 3888 Pisces-Quad Plus LeadSummary page 1…ces Medtronic Neurological Models 3487A and 3887 Leads K923931 Medtronic Neurological Model 3888 Lead K923567 C. Device Description The function of the Medtronic Mattrix@and X-trel@Neurostimulation Systems is accomplished… | 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?
The Medtronic Pisces Z Quad@Model 3890, Pisces 2 Quad Compactm Model 3891, and Pisces Z Quad Plus@Model 3892 Leads for Spinal Cord Stimulation (SCS) are indicated as an 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/K033016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033016: Pisces Z Quad Lead Model, 3890, Pisces Z Quad Compact Lead Model, 3891, Pisces Z Quad Plus Lead Model, 3892.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033016
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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