LEL — Device, Sleep Assessment Class II
FDA product code LEL covers "Device, Sleep Assessment", a Class II medical device regulated under 21 CFR 882.5050. Submissions are reviewed by the Neurology panel. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LEL
- Device Class
- Class II
- Regulation Number
- 882.5050
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252981 | empatica | EmbraceMini | December 22, 2025 |
| K251574 | ambulatory monitoring | Sleep Watch | July 31, 2025 |
| K243513 | pneumowave | DCM (PW-DCM) | April 16, 2025 |
| K233987 | arbor medical innovations | VERABAND | June 17, 2024 |
| K233618 | oxehealth limited | Oxevision Sleep Device | April 3, 2024 |
| K231532 | actigraph | ActiGraph LEAP activity monitor (ActiGraph LEAP) | June 23, 2023 |
| K181077 | actigraph | ActiGraph CentrePoint Insight Watch | May 24, 2018 |
| K151784 | condor instruments ltda. - epp | ActTrust | May 25, 2016 |
| K132764 | camntech | MOTION WATCH AND PRO-DIARY | January 21, 2014 |
| K111514 | sleep performance d.b.a. fatigue science | SBV2, MULTICHARGER MODEL MC10V2 | December 16, 2011 |
| K040986 | cadwell laboratories | CADWELL LIMB MOVEMENT MODULE | July 1, 2004 |
| K040932 | cadwell laboratories | EASYNET BODY POSITION MODULE | July 1, 2004 |
| K003499 | respironics | REMVIEW SLEEP RECORDER, MODEL 320 | February 9, 2001 |
| K981969 | braebon medical | ULTIMA BODY POSITION SENSOR | August 20, 1998 |
| K961817 | koven technology | B SMART MODEL 1 | July 23, 1997 |
| K965079 | neurim pharmaceuticals | SOMNITOR 32K SLEEP ACTIVITY MONITOR | July 10, 1997 |
| K912817 | somnitec | SOMNIMIC (R) | July 26, 1991 |
| K862766 | zygo industries | EPISON, ALERTING SYSTEM FOR EPILEPTICS | March 13, 1987 |
| K792305 | farrall instruments | A SLEEP ASSESSMENT DEVICE | December 20, 1979 |