Device, Sleep Assessment
A sleep assessment device is a neurology diagnostic instrument used to monitor and record physiological parameters during sleep, such as brain activity, respiration, and oxygen saturation, to aid in the evaluation of sleep disorders including sleep apnea. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is LEL, regulated under 21 CFR 882.5050, in the Neurology specialty. No special risk flags apply.
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Basic Information
- Product Code
- LEL
- Device Class
- FDA class 2
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 19 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252981 | EmbraceMini | Dec 22, 2025 | Substantially Equivalent | Empatica S.r.l. |
| K251574 | Sleep Watch | Jul 31, 2025 | Substantially Equivalent | Ambulatory Monitoring, Inc. |
| K243513 | DCM (PW-DCM) | Apr 16, 2025 | Substantially Equivalent | Pneumowave, Ltd. |
| K233987 | VERABAND | Jun 17, 2024 | Substantially Equivalent | Arbor Medical Innovations, LLC |
| K233618 | Oxevision Sleep Device | Apr 03, 2024 | Substantially Equivalent | Oxehealth Limited |
| K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP) | Jun 23, 2023 | Substantially Equivalent | Actigraph, LLC |
| K181077 | ActiGraph CentrePoint Insight Watch | May 24, 2018 | Substantially Equivalent | Actigraph |
| K151784 | ActTrust | May 25, 2016 | Substantially Equivalent | Condor Instruments Ltda. - Epp |
| K132764 | MOTION WATCH AND PRO-DIARY | Jan 21, 2014 | Substantially Equivalent | Camntech, Ltd. |
| K111514 | SBV2, MULTICHARGER MODEL MC10V2 | Dec 16, 2011 | Substantially Equivalent | Sleep Performance D.B.A. Fatigue Science |
| K040986 | CADWELL LIMB MOVEMENT MODULE | Jul 01, 2004 | Substantially Equivalent | Cadwell Laboratories, Inc. |
| K040932 | EASYNET BODY POSITION MODULE | Jul 01, 2004 | Substantially Equivalent | Cadwell Laboratories, Inc. |
| K003499 | REMVIEW SLEEP RECORDER, MODEL 320 | Feb 09, 2001 | Substantially Equivalent | Respironics, Inc. |
| K981969 | ULTIMA BODY POSITION SENSOR | Aug 20, 1998 | Substantially Equivalent | Braebon Medical Corp. |
| K961817 | B SMART MODEL 1 | Jul 23, 1997 | Substantially Equivalent | Koven Technology, Inc. |
| K965079 | SOMNITOR 32K SLEEP ACTIVITY MONITOR | Jul 10, 1997 | Substantially Equivalent | Neurim Pharmaceuticals, Ltd. |
| K912817 | SOMNIMIC (R) | Jul 26, 1991 | Substantially Equivalent | Somnitec, Inc. |
| K862766 | EPISON, ALERTING SYSTEM FOR EPILEPTICS | Mar 13, 1987 | Substantially Equivalent | Zygo Industries, Inc. |
| K792305 | A SLEEP ASSESSMENT DEVICE | Dec 20, 1979 | Substantially Equivalent | Farrall Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.