Cleared Traditional

LMA Fastrach ETT SU

K242495 · Teleflex Medical · Anesthesiology
Apr 2025
Decision
250d
Days
Class 2
Risk

About This 510(k) Submission

K242495 is an FDA 510(k) clearance for the LMA Fastrach ETT SU, a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on April 29, 2025, 250 days after receiving the submission on August 22, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K242495 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2024
Decision Date April 29, 2025
Days to Decision 250 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTR — Tube, Tracheal (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5730

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