510(k) · Cleared
ClearedPMT Sphenoidal Electrode and Accessory, Model 2101-31 and 2102-31 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pmt Corp. · GZL Electrode, Depth
Cleared on Aug 3, 2004 as substantially equivalent to K861031 (Ad-Tech Medical Instrument Corp, 1986) after a 249-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Aug 3, 2004
- Review
- 249 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K861031 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK861031 Wyler Sphenoidal ElectrodeAd-Tech Medical Instrument Corp · 1986
- This deviceK033730 PMT Sphenoidal Electrode and Accessory, Model 2101-31 and 2102-31…Pmt Corp. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861031 | Wyler Sphenoidal Electrode | Ad-Tech Medical Instrument Corp | 1986 | — |
| 0 (this device) | K033730 | PMT Sphenoidal Electrode and Accessory, Model 2101-31 and 2102-31 Series | Pmt Corp. | 2004 | — |
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 |
|---|---|---|---|
| * | K861031 | Wyler Sphenoidal ElectrodeSummary page 1…Substantial Equivalence claim: The PMT Sphenoidal Electrode is substantially equivalent, for the purpose of this 510(K), to the Wyler Sphenoidal Electrode (K861031) manufactured by AD-Tech Medical. Device Description: The PMT Sphenoidal electrode consists of an insulated… | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K861031.
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 SPHENOIDAL Electrode is indicated for Intraoperative recording of electrical signals for Epilepsy monitoring at the surface and subsurface levels of the brain.
It is not intended for long tern monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033730 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033730: PMT Sphenoidal Electrode and Accessory, Model 2101-31 and 2102-31 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033730
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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