Cleared Traditional

FreeStyle Comfort (AS200 / FreeStyle Comfort)

K250671 · Caire, Inc. · Anesthesiology
Jul 2025
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K250671 is an FDA 510(k) clearance for the FreeStyle Comfort (AS200 / FreeStyle Comfort), a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Caire, Inc. (Ball Ground, US). The FDA issued a Cleared decision on July 11, 2025, 128 days after receiving the submission on March 5, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K250671 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2025
Decision Date July 11, 2025
Days to Decision 128 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAW — Generator, Oxygen, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5440

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