Cleared Traditional

Clearo

K242438 · Breas Medical AB · Anesthesiology
May 2025
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K242438 is an FDA 510(k) clearance for the Clearo, a Device, Positive Pressure Breathing, Intermittent (Class II — Special Controls, product code NHJ), submitted by Breas Medical AB (Molnlycke, SE). The FDA issued a Cleared decision on May 16, 2025, 273 days after receiving the submission on August 16, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K242438 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2024
Decision Date May 16, 2025
Days to Decision 273 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code NHJ — Device, Positive Pressure Breathing, Intermittent
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905