Cleared Traditional

AVEA disposable expiratory filter/water trap (11790)

K251133 · Telesair, Inc. · Anesthesiology
May 2025
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K251133 is an FDA 510(k) clearance for the AVEA disposable expiratory filter/water trap (11790), a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Telesair, Inc. (Irvine, US). The FDA issued a Cleared decision on May 8, 2025, 27 days after receiving the submission on April 11, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K251133 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2025
Decision Date May 08, 2025
Days to Decision 27 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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