510(k) · Cleared
Recalled · Class II · 2019Anchor Bolt (as an accessory to Depth Electrodes)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ad-Tech Medical Instrument Corporation · GZL Electrode, Depth
Cleared on Aug 9, 2018 as substantially equivalent to K970418 (Pmt Corp., 1997) after a 58-day review. Its family tree reaches back 2 generations to 1980. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 9, 2018
- Review
- 58 days
- Class
- Class II
- Product code
- GZL
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K802151 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK802151 PMT Depthalon Depth Corticography ElecProgress Mankind Technology · 1980
- 1 generation backK970418 PMT Accessory Depthalon Electrode Anchor Bolt (2103-23-XX)Pmt Corp. · 1997
- This deviceK181544 Anchor Bolt (as an accessory to Depth Electrodes)Ad-Tech Medical Instrument Corporation · 2018
- Descendant · cites it directly · 0 of its ownK223276 Anchor Bolts as Accessories to Depth ElectrodesAd-Tech Medical Instrument Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K223276Anchor Bolts as Accessories to Depth ElectrodesAd-Tech Medical Instrument Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K802151 | PMT Depthalon Depth Corticography Elec | Progress Mankind Technology | 1980 | — |
| −1 | K970418 | PMT Accessory Depthalon Electrode Anchor Bolt (2103-23-XX) | Pmt Corp. | 1997 | — |
| 0 (this device) | K181544 | Anchor Bolt (as an accessory to Depth Electrodes) | Ad-Tech Medical Instrument Corporation | 2018 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K970418 | PMT Accessory Depthalon Electrode Anchor Bolt (2103-23-XX)Summary page 4…21 CFR 882.1330 Product Code: GZL Class II Predicate Device: K970418 Anchor Bolt, Accessory Depthalon® Depth Electrode PMT Corporation 5.1 Product Description… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223276 | Anchor Bolts as Accessories to Depth Electrodes | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 18, 2019 | Class II | Z-2204-2019 | Employee error | On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 and May 31, 2019 Ad-Tech personnel have distributed non-sterile anchor bolt parts to one independent representative and one international… |
| Jun 18, 2019 | Class II | Z-2408-2019 | Employee error | Supplemental information provided with devices may indicate that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 3 companies; a new generation was cleared every 21.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K223276 (Ad-Tech Medical Instrument Corporation, 2023) has gone furthest, with 0 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. 2018, 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 Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode.
Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181544: Anchor Bolt (as an accessory to Depth Electrodes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181544
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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