Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GYC — Predicate Candidate Screening
32 FDA 510(k) clearances under this product code; the 50 most recent screened below.
205 daysmedian FDA review time
446 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250094 | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox ( | Neuralynx, Inc. | 2025-04-14 | 90 | 0 |
| K242618 | Layer 7-T | Precision Neuroscience, Corp. | 2025-03-30 | 208 | 0 |
| K221123 | WISE Cortical Strip (WCS) | Wise S.R.L. | 2022-11-22 | 218 | 0 |
| K211954 | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraop | Spes Medica Srl | 2022-11-10 | 505 | 0 |
| K201931 | Dixi Medical Intraoperative Subdural Electrodes (Strips and | Dixi Medical | 2021-10-02 | 446 | 0 |
| K191346 | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and | Blackrock Microsystems | 2020-02-14 | 270 | 0 |
| K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid | Ad-Tech Medical Instrument Corporation | 2020-01-25 | 267 | 0 |
| K192764 | NeuroOne Cortical Electrode | Neuroone, Inc. | 2019-11-26 | 57 | 0 |
| K183437 | AirRay Subdural Cortical Electrodes | Cortec GmbH | 2019-03-12 | 90 | 0 |
| K180761 | SD LTM STIM Cortical Stimulator | Micromed S.P.A. | 2018-06-18 | 87 | 0 |
| K173684 | g.Estim PRO | G.Tec Medical Engineering GmbH | 2018-05-04 | 154 | 0 |
| K151354 | Cervello STIM | Blackrock Neuromed | 2016-01-27 | 252 | 0 |
| K110410 | MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) | Nihon Kohden Corp. | 2011-08-04 | 171 | 0 |
| K102802 | INTEGRA ELECTRODE TUNNELING NEEDLE | Integra LifeSciences Corporation | 2010-11-23 | 57 | 0 |
| K082629 | S12X WITH ESAX OPTION | Chatten Associates, Inc. | 2009-07-01 | 295 | 0 |
| K082474 | PMT SUBDURAL CORTICAL ELECTRODES | Pmt Corp. | 2009-05-08 | 253 | 0 |
| K072964 | NICOLET CORTICAL STIMULATOR | Cardinal Health, Inc. | 2008-12-30 | 438 | 3 |
| K082250 | AURAGEN CORTICAL SURFACE ELECTRODES | Integra Neurosciences | 2008-10-10 | 63 | 0 |
| K053363 | DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDUR | Ad-Tech Medical Instrument Corp | 2006-05-30 | 179 | 1 |
| K021144 | SUBDURAL STRIP ELECTRODE | Nicolet Biomedical, Inc. | 2002-06-24 | 76 | 0 |
| K992194 | CORTICAL MAPPING UNIT, MODEL CMU | Ad-Tech Medical Instrument Corp | 1999-09-13 | 76 | 0 |
| K961942 | EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND | Radionics, Inc. | 1997-08-18 | 455 | 0 |
| K970587 | AD-TECH SUBDURAL ELECTRODE | Ad-Tech Medical Instrument Corp | 1997-05-09 | 80 | 0 |
| K964224 | STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CO | Pmt Corp. | 1997-03-19 | 147 | 0 |
| K926424 | CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON | Radionics, Inc. | 1993-11-19 | 331 | 0 |
| K923330 | THE WESTERN CORTICAL ELECTRODE ARRAY | University Hospital (London) Development Corp. | 1993-11-09 | 490 | 0 |
| K924226 | OJEMANN CORTICAL STIMULATOR | Radionics, Inc. | 1993-04-21 | 243 | 1 |
| K923803 | AD-TECH SUB DURAL ELECTRODEDS | Ad-Tech Medical Instrument Corp | 1992-10-23 | 86 | 0 |
| K912760 | AD-TECH EPIDURAL PEG ELECTRODE | Ad-Tech Medical Instrument Corp | 1992-01-15 | 205 | 0 |
| K882053 | NICOLET EPIDURAL SPINAL ELECTRODE | Nicolet Instrument Corp. | 1988-10-18 | 155 | 0 |
| K845035 | ELECTRODE FOR NEUROLOGICAL SURGERY 2111 | Progress Mankind Technology | 1985-07-30 | 215 | 0 |
| K850342 | WYLER SUBDURAL STRIP ELECTRODE | Ad-Tech Medical Instrument Corp | 1985-07-30 | 183 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda