Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Earlysense, Ltd. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
198 daysmedian FDA review time
280 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171836 | EarlySense Bed Sensing Unit | Earlysense, Ltd. | 2018-01-04 | 198 | 0 |
| K152911 | EarlySense Insight Sytem | Earlysense, Ltd. | 2016-05-06 | 217 | 0 |
| K151006 | EarlySense Central Display Station (CDS) | Earlysense, Ltd. | 2015-08-31 | 138 | 0 |
| K133661 | CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM | Earlysense, Ltd. | 2014-06-13 | 196 | 0 |
| K131379 | EARLYSENSE | Earlysense, Ltd. | 2013-12-18 | 218 | 0 |
| K121885 | EARLYSENSE CENTRAL DISPLAY SYSTEM | Earlysense, Ltd. | 2012-09-10 | 74 | 0 |
| K120465 | EARLYSENSE (EVERON) SYSTEM | Earlysense, Ltd. | 2012-06-08 | 114 | 0 |
| K110521 | EVERON CENTRAL DISPLAY STATION (CDS) | Earlysense, Ltd. | 2011-04-19 | 55 | 0 |
| K100376 | EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 | Earlysense, Ltd. | 2010-08-06 | 175 | 0 |
| K092062 | EVERON 1.0 | Earlysense, Ltd. | 2010-05-24 | 320 | 0 |
| K082465 | EVERON | Earlysense, Ltd. | 2009-03-25 | 210 | 0 |
| K070375 | EARLYSENSE ES-16 SYSTEM | Earlysense, Ltd. | 2007-11-15 | 280 | 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