Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
POS · Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
189 daysmedian FDA review time
829 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251506 | Nelli (Version 7.11) | Neuro Event Labs OY | 2025-11-21 | 189 | 0 |
| K243199 | NightWatch+ US | Livassured BV | 2025-07-12 | 284 | 0 |
| K250515 | EpiMonitor | Empatica S.r.l. | 2025-06-19 | 118 | 0 |
| K243515 | EpiWatch Monitoring System | Epiwatch, Inc. | 2025-03-07 | 114 | 0 |
| K232915 | EpiMonitor | Empatica S.r.l. | 2024-02-15 | 149 | 0 |
| K200276 | SPEAC System | Brain Sentinel, Inc. | 2021-02-06 | 368 | 0 |
| K182180 | SPEAC System | Brain Sentinel, Inc. | 2019-05-11 | 271 | 0 |
| K181861 | Embrace | Empatica S.r.l. | 2018-12-20 | 161 | 1 |
| K172935 | Embrace | Empatica S.r.l. | 2018-01-26 | 122 | 0 |
| DEN140033 | Companion | Lgch, Inc. | 2017-02-16 | 829 | 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