Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OMC — Predicate Candidate Screening
29 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
396 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261101 | Ceribell Monitor | Ceribell, Inc. | 2026-06-30 | 89 | 0 |
| K251550 | NX01 (NX01) | Naox Technologies Sas | 2025-11-25 | 188 | 0 |
| K251726 | SignalNED System (Model RE) | Forest Devices, Inc. | 2025-09-03 | 90 | 0 |
| K243185 | REMI Remote EEG Monitoring System | Epitel | 2025-03-21 | 172 | 0 |
| K242930 | Natus BrainWatch System | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024-11-19 | 56 | 0 |
| K232779 | QUEX ED; QUEX S | Qx World, Ltd. | 2024-10-11 | 396 | 0 |
| K242306 | SignalNED System (Model RE) | Forest Devices, Inc. | 2024-09-04 | 30 | 0 |
| K230933 | REMI Remote EEG Monitoring System | Epitel, Inc. | 2023-06-30 | 88 | 0 |
| K223628 | NEBA® Compact EEG2R Mobile Headset | Neba Health, LLC | 2023-03-02 | 87 | 0 |
| K221563 | Neurosteer EEG Recorder | Neurosteer, Inc. | 2022-10-24 | 146 | 0 |
| K203827 | REMI | Epitel, Inc. | 2021-03-29 | 90 | 0 |
| K192549 | Byteflies Kit | Byteflies NV | 2020-06-22 | 279 | 0 |
| K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation | 2019-03-19 | 90 | 0 |
| K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017-05-08 | 91 | 0 |
| K152040 | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profile | Advanced Brain Monitoring, Inc. | 2015-10-30 | 100 | 0 |
| K131944 | IEEG | Jordan Neuroscience, Inc. | 2014-04-10 | 287 | 0 |
| K130013 | X4 SYSTEM | Advanced Brain Monitoring, Inc. | 2013-01-31 | 29 | 0 |
| K120447 | X4 | Advanced Brain Monitoring, Inc. | 2012-06-20 | 127 | 0 |
| K110967 | ENTERPRISE ELECTROPHYSIOLOGY SYSTEM | Neuralynx, Inc. | 2011-06-30 | 85 | 0 |
| K092477 | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 | Neurowave Systems, Inc. | 2010-10-29 | 443 | 0 |
| K060523 | NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM | Cyberkinetics, Inc. | 2006-03-28 | 29 | 0 |
| K042309 | BIOSOMNIA-V3 | Oxford Biosignals Limited | 2004-09-08 | 14 | 0 |
| K024245 | ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2004-05-10 | 504 | 0 |
| K021485 | BIOSOMNIA | Oxford Biosignals Limited | 2002-09-11 | 126 | 0 |
| K020335 | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, | Olympic Medical Corp. | 2002-06-18 | 137 | 0 |
| K013863 | CRYSTAL MONITOR MODEL 16 | Cleveland Medical Devices, Inc. | 2002-02-19 | 90 | 0 |
| K001110 | CRYSTAL-EEG MODEL 15 | Cleveland Medical Devices, Inc. | 2000-07-05 | 90 | 0 |
| K970672 | CRYSTAL-EEG MODEL 10 (MODEL 10) | Cleveland Medical Devices, Inc. | 1997-05-22 | 87 | 0 |
| K781130 | ACCESSORY TO ECG ANALYSIS SYS. | Oxford Medilog, Inc. | 1978-08-23 | 49 | 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