Cleared Traditional

EveryWare

K242485 · Breas Medical AB · Anesthesiology
May 2025
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K242485 is an FDA 510(k) clearance for the EveryWare, a Accessory To Continuous Ventilator (respirator) (Class II — Special Controls, product code MOD), submitted by Breas Medical AB (Molnlycke, SE). The FDA issued a Cleared decision on May 20, 2025, 272 days after receiving the submission on August 21, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K242485 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2024
Decision Date May 20, 2025
Days to Decision 272 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MOD — Accessory To Continuous Ventilator (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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