Cleared Traditional

CuffGuard

K243562 · Idmed · Anesthesiology
Aug 2025
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K243562 is an FDA 510(k) clearance for the CuffGuard, a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Idmed (Marseille, FR). The FDA issued a Cleared decision on August 12, 2025, 267 days after receiving the submission on November 18, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K243562 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2024
Decision Date August 12, 2025
Days to Decision 267 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSK — Cuff, Tracheal Tube, Inflatable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5750