Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GWQ — Predicate Candidate Screening
189 FDA 510(k) clearances under this product code; the 50 most recent screened below.
107 daysmedian FDA review time
285 days90th percentile
189clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx ( | Neuroelectrics Barcelona S.L.U. | 2026-06-13 | 30 | 0 |
| K260455 | New Wave System | Zeto, Inc. | 2026-03-13 | 30 | 0 |
| K233403 | Flexset System | Zeto, Inc. | 2024-04-30 | 209 | 0 |
| K231366 | Neuronaute Plus | Bioserenity Sas | 2023-11-09 | 182 | 0 |
| K221959 | Q21 | Neurofield, Inc. | 2023-08-31 | 422 | 0 |
| K231457 | SPARK Scan | Spark Neuro, Inc. | 2023-08-18 | 91 | 0 |
| K221963 | Cumulus Functional Neurophysiology Platform | Cumulus Neuroscience Limited | 2023-04-27 | 296 | 0 |
| K230073 | Okti | Compumedics Limited | 2023-02-09 | 30 | 0 |
| K223644 | Neuronaute with IceCap 2 & IceCap 2 Small | Bioserenity | 2023-01-12 | 37 | 0 |
| K220056 | iSyncWave | iMediSync, Inc. | 2022-08-10 | 216 | 0 |
| K212788 | Seer Home | Seer Medical Pty, Ltd. | 2022-06-16 | 288 | 1 |
| K213900 | WAVi SCAN EEG System and Accessories | Wavi Co. | 2022-05-06 | 143 | 0 |
| K193159 | NeuroAmp II, NeuroAmp II.5s | Corscience GmbH & Co. KG | 2020-12-30 | 411 | 0 |
| K202334 | Neuronaute | Bioserenity Sas | 2020-12-10 | 115 | 0 |
| K201819 | Cadwell Apollo System | Cadwell Industries, Inc. | 2020-09-29 | 90 | 0 |
| K191492 | Maxxi Position Sensor | Neurovirtual USA, Inc. | 2020-04-24 | 324 | 0 |
| K191868 | iCEWav Neuromonitoring Platform | Ice Neurosystems, Inc. | 2020-03-31 | 263 | 0 |
| K192753 | NeuralScan System | Medeia, Inc. | 2020-03-17 | 169 | 0 |
| K181466 | Cadwell Zenith System | Cadwell Industries, Inc. | 2018-09-01 | 89 | 0 |
| K180269 | Cadwell Apollo System | Cadwell Industries, Inc. | 2018-07-17 | 167 | 0 |
| K180290 | Natus Brain Monitor Amplifier | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-06-14 | 133 | 1 |
| K172271 | Trackit T4 EEG Amplifier | Lifelines , Ltd. | 2018-05-04 | 280 | 0 |
| K172735 | WR19 System | Zeto, Inc. | 2018-04-17 | 218 | 0 |
| K180181 | Natus Quantum | Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) | 2018-02-22 | 30 | 0 |
| K173460 | NeuroEEG | Memory MD, Inc. | 2018-02-16 | 101 | 0 |
| K171384 | Micromed BRAIN QUICK system | Micromed S.P.A. | 2018-02-01 | 266 | 1 |
| K170138 | NEURONAUTE | Bioserenity | 2017-12-26 | 343 | 0 |
| K171781 | eVox System | Evoke Neuroscience, Inc. | 2017-12-13 | 181 | 0 |
| K171124 | Nihon Kohden Wireless Input Unit WEE-1200 | Nihon Kohden Corporation | 2017-08-25 | 130 | 0 |
| K170441 | ElectroTek | Mobilemedtek | 2017-06-05 | 111 | 0 |
| K162681 | Enobio Wireless EEG | Neuroelectrics Barcelona S.L.U. | 2017-06-02 | 249 | 0 |
| K163163 | XLTEK EMU40EX EEG Headbox | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2016-12-14 | 34 | 0 |
| K162595 | Trex_HD | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2016-11-04 | 50 | 0 |
| K150498 | Discovery 24 | Brainmaster Technologies, Inc. | 2016-01-26 | 334 | 0 |
| K143233 | Mitsar-EEG | Mitsar Co., Ltd. | 2015-08-13 | 276 | 0 |
| K143440 | Natus Quantum | Natus Medical Incorporated | 2015-04-20 | 139 | 0 |
| K131335 | BWMINI EEG, BWMINIHST, BWMINI PSG | Neurovirtual USA, Inc. | 2015-02-03 | 635 | 0 |
| K131266 | TREZ_HD | Excel-Tech Ltd. (Xltek) | 2014-02-14 | 287 | 0 |
| K133355 | CADWELL FLEX EEG/PSG | Cadwell Industries, Inc. | 2014-01-29 | 90 | 0 |
| K131383 | X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X | Advanced Brain Monitoring, Inc. | 2013-11-27 | 197 | 0 |
| K122196 | CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMI | Blackrock Neuromed, LLC | 2013-05-02 | 282 | 0 |
| K120888 | PSG-1100 SLEEP DIAGNOSTIC SYSTEM | Nihon Kohden Corp. | 2012-11-09 | 231 | 1 |
| K112817 | MICROEEG SYSTEM | Bio-Signal Group Corporation | 2012-06-19 | 265 | 0 |
| K113117 | NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE | Nihon Kohden America, Inc. | 2012-03-22 | 153 | 0 |
| K112353 | GEODESIC EEG MOBILE 100 (GEM 100) | Electrical Geodesics, Inc. | 2012-02-17 | 185 | 0 |
| K112107 | BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS | Neurovirtual USA, Inc. | 2011-10-28 | 98 | 0 |
| K083577 | HARMONIE SYSTEM | Stellate Systems | 2011-08-29 | 999 | 1 |
| K110376 | PE-210AK SWITCH BOX | Nihon Kohden Corp. | 2011-07-29 | 170 | 0 |
| K103129 | ENTROPY EASYFIT SENSOR | GE Healthcare | 2011-07-19 | 270 | 0 |
| K101386 | VIGILANT EEG MONITOR MODEL VIGILANT 2.0 | Infinite Biomedical Technologies, LLC | 2010-07-30 | 73 | 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