Cleared Special

Sleep Watch

K251574 · Ambulatory Monitoring, Inc. · Neurology
Jul 2025
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K251574 is an FDA 510(k) clearance for the Sleep Watch, a Device, Sleep Assessment (Class II — Special Controls, product code LEL), submitted by Ambulatory Monitoring, Inc. (Ardsley, US). The FDA issued a Cleared decision on July 31, 2025, 70 days after receiving the submission on May 22, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K251574 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2025
Decision Date July 31, 2025
Days to Decision 70 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code LEL — Device, Sleep Assessment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5050