510(k) · Cleared
ClearedPMT Platinum Depthalon Depth Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pmt Corporation · GZL Electrode, Depth
Cleared on Jul 14, 2016 after a 379-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.
- Decided
- Jul 14, 2016
- Review
- 379 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK151790 PMT Platinum Depthalon Depth ElectrodePmt Corporation · 2016
- Descendant · cites it directly · 5 of its ownK170959 DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · Recalled
- Descendant · cites it directly · 5 of its ownK163355 Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth…Ad-Tech Medical Instrument Corporation · 2017 · Recalled
- Descendant · 2 generations on · 2 of its ownK211367 Evo sEEG SystemNeuroone Medical Technologies Corp. · 2021
- Descendant · 2 generations on · 1 of its ownK213170 SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK222404 Evo® sEEG SystemNeuroone Medical Technologies Corp. · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · cites it directly5descendants
- K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer…Ad-Tech Medical Instrument Corporation · 2017 · cites it directly5descendants
- K211367Evo sEEG SystemNeuroone Medical Technologies Corp. · 2021 · 2 generations on2descendants
- K213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd. · 2023 · 2 generations on1descendant
- K222404Evo® sEEG SystemNeuroone Medical Technologies Corp. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K151790 | PMT Platinum Depthalon Depth Electrode | Pmt Corporation | 2016 | — |
| +1 | K170959 | DIXI Medical Microdeep Depth Electrode | Dixi Medical | 2017 | 9 |
| +1 | K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes… | Ad-Tech Medical Instrument Corporation | 2017 | 5 |
| +2 | K211367 | Evo sEEG System | Neuroone Medical Technologies Corp. | 2021 | — |
| +2 | K213170 | SENSOSEEG Depth Electrodes | Sensomedical Labs, Ltd. | 2023 | — |
| +3 | K222404 | Evo® sEEG System | Neuroone Medical Technologies Corp. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GZL? 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 GZL device
- #1 K253970 Wovyn Depth Electrodescore 13.3 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (11)
See all 113 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?
- Of its descendants, K170959 (Dixi Medical, 2017) has gone furthest, with 5 descendants of its own.
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GZL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZL
206in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZL
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZL
12in 2025
MAUDE reports naming product code GZL, 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 | 3 | 166 | 0 | 0 |
| 2008 | 0 | — | 3 | 8 |
| 2009 | 1 | — | 2 | 5 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 1 | — | 0 | 25 |
| 2014 | 1 | — | 1 | 7 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 9 |
| 2017 | 4 | 222 | 0 | 3 |
| 2018 | 3 | 58 | 0 | 2 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 1 | — | 0 | 24 |
| 2021 | 3 | 262 | 9 | 13 |
| 2022 | 3 | 90 | 0 | 10 |
| 2023 | 3 | 206 | 0 | 30 |
| 2024 | 0 | — | 3 | 16 |
| 2025 | 2 | — | 0 | 12 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Platinum Depthalon® Depth Electrodes are intended for temporary (<30 day) use with recording, monitoring, and stimulation equipment for the recording, monitoring and stimulation of electrical signals in the subsurface of the brain,
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151790: PMT Platinum Depthalon Depth Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151790
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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