# K082474: PMT Subdural Cortical Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Pmt Corp.
- Decided: May 8, 2009 after 253 days
- Product code: GYC (Electrode, Cortical)
- Device class: 2
- Regulation: 21 CFR 882.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K850342 (1985). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964224: Stainless Steel Cortac Cortical Electrode (2111)/Plantinum Cortac Cortical Electrode, Pmt Corp. (1997) Summary page 1.
- K053363: Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes, Intraoperative Subdural Electrodes, Ad-Tech Medical Instrument Corp (2006) Summary page 1.

## Most influential descendants
- K192764: NeuroOne Cortical Electrode (2019), 0 descendants of its own

## Indications for use
Catalog Numbers 21 10-XXX: The Subdural Cortical Electrodes (Dual Side Macro Electrodes, Dual Side Micro Electrodes, Dual Side Macro-Micro Electrodes, Dual Sided Hemispherical Macro Electrodes, Dual Sided Hemispherical Micro Electrodes, Dual Side Hemispherical Macro-Micro Electrodes, Macro Grids, Macro Strip, Macro-Micro Grids, Macro-Micro Strips, Micro Grids, and Micro Strips.) are intended for temporary (<30 day) use with recording, monitoring, and stimulation equipment for the recording, monitoring and stimulation of electrical signals on the surface of the brain. This device is restricted to the sale by or on the order of a physician.

Source page: https://510kreport.com/device/K082474
Methodology: https://510kreport.com/methodology