Cleared Traditional

CuffTrek

K242642 · Shanghai Longmann Tech Co., Ltd. · Anesthesiology
Mar 2025
Decision
185d
Days
Class 2
Risk

About This 510(k) Submission

K242642 is an FDA 510(k) clearance for the CuffTrek, a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Shanghai Longmann Tech Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 7, 2025, 185 days after receiving the submission on September 3, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K242642 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2024
Decision Date March 07, 2025
Days to Decision 185 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