510(k) · Cleared
ClearedMulti-Lead Trialing Cable Model 355531
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Cleared on Oct 26, 2010 as substantially equivalent to K960631 (Medtronic Vascular, 1996) after a 54-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Oct 26, 2010
- Review
- 54 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960631 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK960631 Medtronic Model 3550 Accessory Kit (Contents) 3550-OXMedtronic Vascular · 1996
- This deviceK102523 Multi-Lead Trialing Cable Model 355531Medtronic, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960631 | Medtronic Model 3550 Accessory Kit (Contents) 3550-OX | Medtronic Vascular | 1996 | — |
| 0 (this device) | K102523 | Multi-Lead Trialing Cable Model 355531 | Medtronic, Inc. | 2010 | — |
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? (1)
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 |
|---|---|---|---|
| * | K960631 | Medtronic Model 3550 Accessory Kit (Contents) 3550-OXSummary page 2…cteristics is included in the table below: Description Predicate Device: Subject Device: Model Cleared 3550-03 OR 355531 Multi-Lead Screening Cable Trialing Cable Market K960631 K 102523 (Subject device) Release Information Indications The Medtronic Model The Medtronic Model for Use 3550-03 OR Screening 35… | 1996 |
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?
- Its one ancestor has no recall.
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. 2010, 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 Medtronic Model 355531 Multi-Lead Trialing Cable (MLTC) is indicated for use with Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) systems for the treatment of intractable pain of the trunk or limbs.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102523: Multi-Lead Trialing Cable Model 355531.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102523
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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