Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LEL — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
96 daysmedian FDA review time
329 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252981 | EmbraceMini | Empatica S.r.l. | 2025-12-22 | 96 | 0 |
| K251574 | Sleep Watch | Ambulatory Monitoring, Inc. | 2025-07-31 | 70 | 0 |
| K243513 | DCM (PW-DCM) | Pneumowave, Ltd. | 2025-04-16 | 155 | 0 |
| K233987 | VERABANDâ„¢ | Arbor Medical Innovations, LLC | 2024-06-17 | 182 | 0 |
| K233618 | Oxevision Sleep Device | Oxehealth Limited | 2024-04-03 | 142 | 0 |
| K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP) | Actigraph, LLC | 2023-06-23 | 28 | 0 |
| K181077 | ActiGraph CentrePoint Insight Watch | Actigraph | 2018-05-24 | 30 | 0 |
| K151784 | ActTrust | Condor Instruments Ltda. - Epp | 2016-05-25 | 329 | 0 |
| K132764 | MOTION WATCH AND PRO-DIARY | Camntech, Ltd. | 2014-01-21 | 139 | 0 |
| K111514 | SBV2, MULTICHARGER MODEL MC10V2 | Sleep Performance D.B.A. Fatigue Science | 2011-12-16 | 198 | 0 |
| K040986 | CADWELL LIMB MOVEMENT MODULE | Cadwell Laboratories, Inc. | 2004-07-01 | 77 | 0 |
| K040932 | EASYNET BODY POSITION MODULE | Cadwell Laboratories, Inc. | 2004-07-01 | 83 | 0 |
| K003499 | REMVIEW SLEEP RECORDER, MODEL 320 | Respironics, Inc. | 2001-02-09 | 88 | 0 |
| K981969 | ULTIMA BODY POSITION SENSOR | Braebon Medical Corp. | 1998-08-20 | 77 | 0 |
| K961817 | B SMART MODEL 1 | Koven Technology, Inc. | 1997-07-23 | 439 | 0 |
| K965079 | SOMNITOR 32K SLEEP ACTIVITY MONITOR | Neurim Pharmaceuticals, Ltd. | 1997-07-10 | 203 | 0 |
| K912817 | SOMNIMIC (R) | Somnitec, Inc. | 1991-07-26 | 66 | 0 |
| K862766 | EPISON, ALERTING SYSTEM FOR EPILEPTICS | Zygo Industries, Inc. | 1987-03-13 | 234 | 0 |
| K792305 | A SLEEP ASSESSMENT DEVICE | Farrall Instruments, Inc. | 1979-12-20 | 34 | 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