510(k) · Cleared
ClearedPMT Depthalon Depth Corticography Elec
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Progress Mankind Technology · GZL Electrode, Depth
Cleared on Nov 19, 1980 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Nov 19, 1980
- Review
- 72 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK802151 PMT Depthalon Depth Corticography ElecProgress Mankind Technology · 1980
- 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 · cites it directly · 2 of its ownK970418 PMT Accessory Depthalon Electrode Anchor Bolt (2103-23-XX)Pmt Corp. · 1997
- Descendant · 2 generations on · 1 of its ownK201678 iCE-SG Subcutaneous Electrode ArraysIce Neurosystems, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK181544 Anchor Bolt (as an accessory to Depth Electrodes)Ad-Tech Medical Instrument Corporation · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK250363 Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth…Beijing Sinovation Medical Technology Co., Ltd. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer…Ad-Tech Medical Instrument Corporation · 2017 · cites it directly5descendants
- K970418PMT Accessory Depthalon Electrode Anchor Bolt (2103-23-XX)Pmt Corp. · 1997 · cites it directly2descendants
- K201678iCE-SG Subcutaneous Electrode ArraysIce Neurosystems, Inc. · 2021 · 2 generations on1descendant
- K181544Anchor Bolt (as an accessory to Depth Electrodes)Ad-Tech Medical Instrument Corporation · 2018 · 2 generations on1descendant
- K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth…Beijing Sinovation Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K802151 | PMT Depthalon Depth Corticography Elec | Progress Mankind Technology | 1980 | — |
| +1 | K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes… | Ad-Tech Medical Instrument Corporation | 2017 | 5 |
| +1 | K970418 | PMT Accessory Depthalon Electrode Anchor Bolt (2103-23-XX) | Pmt Corp. | 1997 | — |
| +2 | K201678 | iCE-SG Subcutaneous Electrode Arrays | Ice Neurosystems, Inc. | 2021 | — |
| +2 | K181544 | Anchor Bolt (as an accessory to Depth Electrodes) | Ad-Tech Medical Instrument Corporation | 2018 | 2 |
| +2 | K250363 | Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode… | Beijing Sinovation Medical Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
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?
- Of its descendants, K163355 (Ad-Tech Medical Instrument Corporation, 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.
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 | — |
https://510kreport.com/device/K802151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K802151: PMT Depthalon Depth Corticography Elec.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K802151
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026