Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OLT — Predicate Candidate Screening
55 FDA 510(k) clearances under this product code; the 50 most recent screened below.
160 daysmedian FDA review time
303 days90th percentile
55clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253767 | UB ERP System | Universal Brain | 2026-06-30 | 217 | 0 |
| K251881 | HippoMind (v1.0) | Hippoclinic | 2025-12-03 | 168 | 0 |
| K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier | Nihon Kohden Corporation | 2025-10-09 | 161 | 0 |
| K240593 | VEEGix EEG System | NeuroServo, Inc. | 2024-08-23 | 175 | 0 |
| K220254 | Neuron-Spectrum-AM with Neuron-Spectrum.NET Software | Neurosoft , Ltd. | 2022-11-30 | 303 | 0 |
| K213299 | Wireless EEG System | Pascall Systems, Inc. | 2022-05-11 | 222 | 0 |
| K191322 | E-EEGX, N-EEGX | GE Healthcare Finland Oy | 2020-01-22 | 252 | 0 |
| K192572 | CNS Envision | Moberg Research, Inc. | 2019-12-17 | 90 | 0 |
| K190760 | Cadwell Bolt Software | Cadwell Industries, Inc. | 2019-11-23 | 243 | 0 |
| K143487 | Lifelines iEEG | Kvikna Ehf | 2015-08-21 | 256 | 0 |
| K142834 | DiscoverEEG System, Model DE-401 | Neurowave Systems, Inc. | 2015-06-23 | 266 | 0 |
| K133995 | NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE | Neurosoft , Ltd. | 2015-06-19 | 540 | 0 |
| K141316 | COGNISION EEG/EP SYSTEM | Neuronetrix Solutions | 2015-02-13 | 269 | 0 |
| K142064 | GALILEO NT | Eb Neuro S.P.A. | 2015-02-13 | 198 | 0 |
| K131882 | GEODESICEEG SYSTEM 400 SERIES (GES 400) | Electrical Geodesics, Inc. | 2014-02-12 | 232 | 1 |
| K123665 | LIFELINES IEEG | Kvikna Ehf | 2013-03-25 | 117 | 0 |
| K091963 | VIGILANT EEG MONITOR, VIGILANT 2.0 | Infinite Biomedical Technologies, LLC | 2009-11-06 | 128 | 0 |
| K082886 | ZOOM-100DC | Brainscope Company, Inc. | 2009-08-10 | 314 | 0 |
| K080546 | NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A | Nihon Kohden America, Inc. | 2008-08-29 | 183 | 0 |
| K072382 | MODEL I-2000 MONITOR | Infinite Biomedical Technologies | 2008-02-15 | 175 | 0 |
| K063797 | GEODESIC EEG SYSTEM 300 | Electrical Geodesics, Incorporated | 2007-01-25 | 34 | 0 |
| K062533 | BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV | Neurovirtual USA, Inc. | 2006-12-22 | 115 | 0 |
| K051883 | DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG | GE Healthcare | 2005-08-05 | 24 | 0 |
| K033010 | BRM2 BRAIN MONITOR | Brainz Instruments , Ltd. | 2003-10-10 | 14 | 0 |
| K030489 | BRM2 BRAIN MONITOR | Brainz Instruments , Ltd. | 2003-05-02 | 77 | 0 |
| K023536 | NUAMPS | Neuroscan | 2003-01-15 | 86 | 0 |
| K001564 | SCAN LT40 (40 CHANNELS) | Neuro Scan Labs | 2000-11-24 | 189 | 0 |
| K001324 | SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI | Neuro Scan Labs | 2000-07-11 | 76 | 0 |
| K000892 | DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, | Datex-Ohmeda, Inc. | 2000-06-16 | 88 | 0 |
| K000068 | COMPUMEDICS E-SERIES EEG SYSTEM | Compumedics Neuro Science Pty , Ltd. | 2000-03-13 | 63 | 1 |
| K991012 | SIEMENS INFINITY EEG POD | Siemens Medical Solutions USA, Inc. | 1999-06-24 | 90 | 0 |
| K982351 | LUNA | Stellate Systems | 1998-07-29 | 23 | 0 |
| K955577 | ECLIPSE VERSION 3.0 | Stellate Systems | 1996-09-20 | 317 | 0 |
| K954157 | DG PORTABLE SYSTEM | Medelec , Ltd. | 1996-01-17 | 134 | 0 |
| K952347 | A-1050 EEG MONITOR | Aspect Medical Systems, Inc. | 1996-01-16 | 242 | 0 |
| K953799 | DG EXAMINER PLUS | Medelec , Ltd. | 1995-11-08 | 86 | 0 |
| K951724 | QUANTITATIVE EEG ANALYSIS SOFTWARE | Neuroconcepts, Inc. | 1995-07-14 | 91 | 0 |
| K940811 | BRAINTRACE | Brainstorms Monitoring Corp. | 1995-05-02 | 434 | 0 |
| K915820 | NEUROSEARCH-24 OR NRS-24 | Lexicor Medical Technology, Inc. | 1995-02-08 | 1136 | 0 |
| K934050 | TOPOGRAPHIC BRAIN MAPPING OPTION | Biosound, Inc. | 1994-02-03 | 168 | 0 |
| K923043 | SPECTRAL EEG MONITOR MODEL A1000 | Aspect Medical Systems, Inc. | 1992-12-03 | 162 | 0 |
| K913051 | SPECTRAL EEG MONITOR MODEL B500 | Biometrak Corp. | 1991-08-20 | 42 | 0 |
| K894889 | TECA NEUROMAPPER 386 | Teca, Inc. | 1989-12-22 | 143 | 0 |
| K894088 | TECA NEUROMAPPER 1620, BRAIN MAPPER | Teca, Inc. | 1989-11-15 | 160 | 0 |
| K874733 | GUARDIAN, EEG BRAIN MONITORING SYSTEM | Tracor Northern, Inc. | 1988-02-29 | 103 | 0 |
| K863783 | HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM | Hzi Research Center | 1987-03-03 | 158 | 0 |
| K863650 | QUANTIMAP III | Quantified Signal Imaging, Inc. | 1986-09-26 | 8 | 0 |
| K860378 | MIND MAP (20 CHANNEL EEG) | Mind Systems Corp. | 1986-08-12 | 190 | 0 |
| K853420 | CARTOVAR BRAIN MAPPING ELECTRODIAGNOSTICS | Alvar | 1986-02-07 | 177 | 0 |
| K852587 | CDSA(COLOR DENSITY, SPECTRAL ARRRAY) | Tracor Northern, Inc. | 1985-08-16 | 59 | 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