Cleared Traditional

Personalized Therapy Comfort Settings (PTCS)

K251657 · ResMed Corp · Anesthesiology

Dec 2025

Decision

189d

Days

Class 2

Risk

About This 510(k) Submission

K251657 is an FDA 510(k) clearance for the Personalized Therapy Comfort Settings (PTCS), a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by ResMed Corp (San Diego, US). The FDA issued a Cleared decision on December 5, 2025, 189 days after receiving the submission on May 30, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K251657 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2025
Decision Date	December 05, 2025
Days to Decision	189 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF