Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OMA — Predicate Candidate Screening
16 FDA 510(k) clearances under this product code; the 50 most recent screened below.
192 daysmedian FDA review time
323 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192889 | Neo | Eemagine Medical Imaging Solutions GmbH | 2020-01-30 | 112 | 0 |
| K163644 | Nihon Kohden QP-160AK EEG Trend Program | Nihon Kohden Corporation | 2017-05-19 | 147 | 0 |
| K161027 | Cadwell AmpliScan | Cadwell Industries, Inc. | 2016-11-08 | 210 | 0 |
| K152301 | Background Pattern Classification [BPc(TM)] | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2016-06-03 | 294 | 0 |
| K130238 | NIHON KOHDEN AE-918P NEURO UNIT | Nihon Kohden Corp. | 2015-03-04 | 762 | 0 |
| K131789 | CEREBRALOGIK- AEEG | Mennen Medical , Ltd. | 2013-12-27 | 192 | 0 |
| K123079 | OLYMPIC BRAINZ MONITOR | Excel-Tech Ltd. (Xltek) | 2013-05-08 | 219 | 2 |
| K120485 | NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DS | Nihon Kohden America, Inc. | 2012-03-16 | 28 | 0 |
| K092573 | NIHON KOHDEN QP-160AK EEG TREND PROGRAM | Nihon Kohden America, Inc. | 2010-07-09 | 323 | 0 |
| K093949 | OLYMPIC BRAINZ MONITOR MODEL OBM70001 | Natus Medical, Inc. | 2010-06-16 | 175 | 0 |
| K081551 | TWIN NEUROTRAC-III | Astro-Med, Inc. | 2008-12-24 | 204 | 0 |
| K080217 | COMPONENT NEUROMONITORING SYSTEM | Moberg Research, Inc. | 2008-11-05 | 281 | 1 |
| K071449 | BRM3 BRAIN MONITOR | Brainz Instruments , Ltd. | 2007-09-14 | 113 | 0 |
| K031149 | OLYMPIC CFM 6000 | Olympic Medical Corp. | 2003-05-14 | 34 | 0 |
| K983229 | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM | Olympic Medical Corp. | 1999-03-23 | 189 | 0 |
| K791580 | CEREBRAL FUNCTION MONITOR 870 | Applied Medical Research | 1979-09-04 | 18 | 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