Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OLZ — Predicate Candidate Screening
37 FDA 510(k) clearances under this product code; the 50 most recent screened below.
149 daysmedian FDA review time
268 days90th percentile
37clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253390 | SOMNUM (SOMNUM) | Honeynaps Co., Ltd. | 2026-06-27 | 270 | 0 |
| K253668 | Onera SleepMap (SLEEPMAP) | Onera B.V. | 2026-03-08 | 107 | 0 |
| K250851 | Hypnos (369054-200) | Cadwell Industries, Inc. | 2025-12-14 | 268 | 0 |
| K252330 | DeepRESP | Nox Medical Ehf | 2025-11-17 | 115 | 0 |
| K250058 | NEAT 001 | Brain Electrophysiology Laboratory Company, LLC | 2025-04-10 | 90 | 0 |
| K241960 | DeepRESP | Nox Medical Ehf | 2025-03-14 | 254 | 0 |
| K242094 | Dreem 3S | Beacon Biosignals, Inc. | 2024-11-22 | 128 | 0 |
| K233438 | SleepStageML | Beacon Biosignals, Inc. | 2024-03-08 | 147 | 0 |
| K223539 | Dreem 3S | Beacon Biosignals, Inc. | 2023-08-18 | 268 | 0 |
| K223922 | SOMNUM (V.1.1.2.) | Honeynaps Co., Ltd. | 2023-08-16 | 229 | 0 |
| K221179 | SomnoMetry | Neumetry Medical, Inc. | 2022-09-21 | 149 | 0 |
| K210034 | EnsoSleep | Ensodata, Inc. | 2021-06-16 | 161 | 0 |
| K202142 | Sleepware G3 | Respironics, Inc. | 2020-10-29 | 90 | 0 |
| K192469 | Nox Sleep System | Nox Medical | 2019-11-13 | 65 | 0 |
| K182227 | Esprit Nova | Neurozone Msh Incorporated | 2019-01-17 | 154 | 0 |
| K173366 | NicoletOne | Natus Neurology Incorporated | 2018-07-20 | 267 | 0 |
| K163617 | REMbrandt | Embla Systems | 2017-04-11 | 110 | 0 |
| K162627 | EnsoSleep | Ensodata, Inc. | 2017-03-31 | 192 | 0 |
| K162140 | RemLogic | Embla Systems | 2016-12-01 | 122 | 0 |
| K153353 | SANDMAN ELITE | Embla Systems | 2016-06-23 | 216 | 0 |
| K153412 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2016-03-14 | 110 | 0 |
| K142988 | Sleepware G3 | Respironics, Inc. | 2015-03-16 | 151 | 0 |
| K142825 | Zmachine | Consolidated Research of Richmond, Inc. | 2015-01-20 | 112 | 0 |
| K130007 | SLEEP PROFILER | Advanced Brain Monitoring, Inc. | 2013-04-17 | 105 | 0 |
| K120450 | SLEEP PROFILER | Advanced Brain Monitoring, Inc. | 2012-09-19 | 218 | 0 |
| K090277 | NATUS SLEEPWORKS, MODEL 104017 | Excel-Tech Ltd. (Xltek) | 2011-04-19 | 804 | 0 |
| K062943 | POLYSMITH SLEEP SYSTEM, MODEL NTI5498 | Neurotronics, Inc. | 2007-05-09 | 223 | 0 |
| K040595 | ALICE 5 | Respironics, Inc. | 2004-03-18 | 10 | 1 |
| K002622 | BIOSLEEP | Oxford Biosignals Limited | 2000-10-23 | 61 | 0 |
| K963631 | SLEEP STUDY ANALYSIS (SSA) VERSION 96.10 | Omega Results | 1997-04-02 | 203 | 0 |
| K961636 | MEDILOG VISION | Oxford Instruments, Plc. | 1997-01-17 | 263 | 0 |
| K915856 | SENSORMEDICS 4000 SERIES SLEEP SYSTEM | Sensor Medics Corp. | 1992-10-26 | 304 | 0 |
| K894155 | SLEEPSCAN | Biologic Systems Corp. | 1990-01-26 | 226 | 0 |
| K891383 | MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM | Oxford Medilog, Inc. | 1989-06-01 | 84 | 0 |
| K890513 | SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS) | Micro Tronics Corp. | 1989-04-28 | 86 | 0 |
| K871990 | MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS. | Oxford Medilog, Inc. | 1987-10-07 | 134 | 0 |
| K862527 | SLEEP ANALYZING COMPUTER | Micro Tronics Corp. | 1986-10-06 | 96 | 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