Cleared Special

DeltaWave Nasal Pillow System

K253939 · RemSleep Holdings, Inc. · Anesthesiology

Jan 2026

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K253939 is an FDA 510(k) clearance for the DeltaWave Nasal Pillow System, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by RemSleep Holdings, Inc. (Blackshear, US). The FDA issued a Cleared decision on January 7, 2026, 29 days after receiving the submission on December 9, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K253939 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 09, 2025
Decision Date	January 07, 2026
Days to Decision	29 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF