510(k) · Cleared
ClearedOne Step Connect Leads (Quattrode, Octrode, Cervitrode)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuromed, Inc. · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Cleared on May 22, 1996 as substantially equivalent to K810182 (Electronic Diagnostics, Inc., 1981) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1981. 3 later devices descend from it.
- Decided
- May 22, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K810182 (1981). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK810182 Programmable Spinal Coral Stim. SystemElectronic Diagnostics, Inc. · 1981
- This deviceK960728 One Step Connect Leads (Quattrode, Octrode, Cervitrode)Neuromed, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK991784 Renew Lead ExtensionAdvanced Neuromodulation Systems · 1999
- Descendant · 2 generations on · 0 of its ownK992946 Renew ReceiverAdvanced Neuromodulation Systems · 1999
- Descendant · cites it directly · 0 of its ownK990469 Lamitrode LeadsAdvanced Neuromodulation Systems · 1999
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810182 | Programmable Spinal Coral Stim. System | Electronic Diagnostics, Inc. | 1981 | — |
| 0 (this device) | K960728 | One Step Connect Leads (Quattrode, Octrode, Cervitrode) | Neuromed, Inc. | 1996 | — |
| +1 | K991784 | Renew Lead Extension | Advanced Neuromodulation Systems | 1999 | — |
| +2 | K992946 | Renew Receiver | Advanced Neuromodulation Systems | 1999 | — |
| +1 | K990469 | Lamitrode Leads | Advanced Neuromodulation Systems | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 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 |
|---|---|---|---|
| * | K810182 | Programmable Spinal Coral Stim. SystemSummary page 2…ame: Implanted Spinal Cord Stimulator for Pain Relief Neuromed, Inc., currently markets spinal cord stimulator systems with polyethylene lead insulators under 510(k) # K810182A and K860158A. Device Description: Neuromed, Inc.’s One-Step Connect™ Leads are implantable devices consisting of spaced elect… | 1981 |
| * | K860158 | 8-Channel Multiprog Implant Spinal Cord StimulatorSummary page 2…d Spinal Cord Stimulator for Pain Relief Neuromed, Inc., currently markets spinal cord stimulator systems with polyethylene lead insulators under 510(k) # K810182A and K860158A. Device Description: Neuromed, Inc.’s One-Step Connect™ Leads are implantable devices consisting of spaced electrodes connect… | 1986 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K991784 (Advanced Neuromodulation Systems, 1999) has gone furthest, with 1 descendant of its own.
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?
Neuromed, Inc.’s One-Step Connect™ Leads are intended to be used with Neuromed trial extensions and/or receivers, transmitters, and antennae to electrically stimulate spinal cord fiber tracts for treatment of chronic pain of the extremities and/or trunk.
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/K960728 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960728: One Step Connect Leads (Quattrode, Octrode, Cervitrode).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960728
Report an extraction error
Are you the manufacturer?
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