Cleared Traditional

K242495 - LMA Fastrach ETT SU

K242495 is the FDA 510(k) clearance for LMA Fastrach ETT SU by Teleflex Medical. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 250-day FDA review.

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

K242495 is an FDA 510(k) clearance for the LMA Fastrach ETT SU. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on April 29, 2025 after a review of 250 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Teleflex Medical devices

Submission Details

510(k) Number K242495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 140d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTR Tube, Tracheal (w/wo Connector)

All 107
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