510(k) · Cleared
ClearedPMT Accessory Depthalon Electrode Anchor Bolt (2103-23-XX)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pmt Corp. · GZL Electrode, Depth
Cleared on Apr 29, 1997 as substantially equivalent to K802151 (Progress Mankind Technology, 1980) after an 84-day review. Its family tree reaches back 1 generation to 1980. 2 later devices descend from it.
- Decided
- Apr 29, 1997
- Review
- 84 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K802151 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK802151 PMT Depthalon Depth Corticography ElecProgress Mankind Technology · 1980
- This deviceK970418 PMT Accessory Depthalon Electrode Anchor Bolt (2103-23-XX)Pmt Corp. · 1997
- Descendant · cites it directly · 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 ownK223276 Anchor Bolts as Accessories to Depth ElectrodesAd-Tech Medical Instrument Corporation · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K802151 | PMT Depthalon Depth Corticography Elec | Progress Mankind Technology | 1980 | — |
| 0 (this device) | K970418 | PMT Accessory Depthalon Electrode Anchor Bolt (2103-23-XX) | Pmt Corp. | 1997 | — |
| +1 | K181544 | Anchor Bolt (as an accessory to Depth Electrodes) | Ad-Tech Medical Instrument Corporation | 2018 | 2 |
| +2 | K223276 | Anchor Bolts as Accessories to Depth Electrodes | Ad-Tech Medical Instrument Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 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 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? (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 |
|---|---|---|---|
| * | K802151 | PMT Depthalon Depth Corticography Elec Our OCR of the scanned summary read “K802151” beside “510(k)”; FDA’s K802151 is the only number that fits it and carries the summary’s name for the device. Summary page 2…ion Summary Anchor Bolt, Depthalon Electrode Accessory PMT® Corporation January 27, 1997 Once installed on to the skull a PMT Dcptha]on® Depth Electrode (510(k) number K802151 and K802152) can be inserted into the Anchor Bolt Screw Cap Port Hole through the Silicone Gasket and into the cranium. The PMT D… | 1980 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181544 | Anchor Bolt (as an accessory to Depth Electrodes) | 2018 | 1 |
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 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 | — |
What is it indicated for?
The PMT Depth Electrode Anchor Bolt is an accessory used in cases where it’s necessary to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode during intraoperative electroclincal characterization.
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/K970418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970418: PMT Accessory Depthalon Electrode Anchor Bolt (2103-23-XX).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970418
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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