Atlas FDA

LEL

19 FDA 510(k) clearances · Product code

96 daysmedian time to decision
329 days90th percentile
19clearances measured

FDA profile

Official device name
Device, Sleep Assessment
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5050
Medical specialty
Neurology
Adverse events (MAUDE)
1992: 2 · 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
EmbraceMini (K252981)Empatica S.r.l.2025-12-22
Sleep Watch (K251574)Ambulatory Monitoring, Inc.2025-07-31
DCM (PW-DCM) (K243513)Pneumowave, Ltd.2025-04-16
VERABANDâ„¢ (K233987)Arbor Medical Innovations, LLC2024-06-17
Oxevision Sleep Device (K233618)Oxehealth Limited2024-04-03
ActiGraph LEAP activity monitor (ActiGraph LEAP) (K231532)Actigraph, LLC2023-06-23
ActiGraph CentrePoint Insight Watch (K181077)Actigraph2018-05-24
ActTrust (K151784)Condor Instruments Ltda. - Epp2016-05-25
MOTION WATCH AND PRO-DIARY (K132764)Camntech, Ltd.2014-01-21
SBV2, MULTICHARGER MODEL MC10V2 (K111514)Sleep Performance D.B.A. Fatigue Science2011-12-16
CADWELL LIMB MOVEMENT MODULE (K040986)Cadwell Laboratories, Inc.2004-07-01
EASYNET BODY POSITION MODULE (K040932)Cadwell Laboratories, Inc.2004-07-01
REMVIEW SLEEP RECORDER, MODEL 320 (K003499)Respironics, Inc.2001-02-09
ULTIMA BODY POSITION SENSOR (K981969)Braebon Medical Corp.1998-08-20
B SMART MODEL 1 (K961817)Koven Technology, Inc.1997-07-23
SOMNITOR 32K SLEEP ACTIVITY MONITOR (K965079)Neurim Pharmaceuticals, Ltd.1997-07-10
SOMNIMIC (R) (K912817)Somnitec, Inc.1991-07-26
EPISON, ALERTING SYSTEM FOR EPILEPTICS (K862766)Zygo Industries, Inc.1987-03-13
A SLEEP ASSESSMENT DEVICE (K792305)Farrall Instruments, Inc.1979-12-20

Track LEL automatically

Every clearance here is in the API, with alerts when new ones post.