510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LELClass II

Device, Sleep Assessment

21 CFR 882.5050 / Neurology
FDA source (opens on fda.gov)

LEL is the FDA product code for Device, Sleep Assessment, a class II device type, regulated under 21 CFR 882.5050. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LEL
Device name
Device, Sleep Assessment
Regulation
21 CFR 882.5050
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
19
Ingested recalls
0

Clearances, product code LEL

By decision year
19 clearances under product code LEL with a decision year between 1979 and 2025, 2025 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LEL by decision year
YearClearances
19791
19871
19911
19972
19981
20011
20042
20111
20141
20161
20181
20231
20242
20253

Applicants with the most clearances

Product code LEL
Applicants holding the most 510(k) clearances under product code LEL
ApplicantClearances
ActiGraph L.L.C.2
Cadwell Laboratories, Inc.2
Ambulatory Monitoring, Inc.1
Arbor Medical Innovations, LLC1
Braebon Medical Corp.1
Camntech1
Condor Instruments Ltda. - Epp1
EMPATICA S.r.l.1
Farrall Instruments, Inc.1
Koven Technology, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order