Cleared Traditional

SleepRes PAP System

K251770 · Sleepres, Inc. · Anesthesiology

Dec 2025

Decision

188d

Days

Class 2

Risk

About This 510(k) Submission

K251770 is an FDA 510(k) clearance for the SleepRes PAP System, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Sleepres, Inc. (Murfreesboro, US). The FDA issued a Cleared decision on December 15, 2025, 188 days after receiving the submission on June 10, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K251770 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 2025
Decision Date	December 15, 2025
Days to Decision	188 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF