# K033730: PMT Sphenoidal Electrode and Accessory, Model 2101-31 and 2102-31 Series

- Pathway: 510(k) (Traditional)
- Applicant: Pmt Corp.
- Decided: Aug 3, 2004 after 249 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K861031 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861031: Wyler Sphenoidal Electrode, Ad-Tech Medical Instrument Corp (1986) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K033730
Methodology: https://510kreport.com/methodology