Cleared Traditional

Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)

K241451 · Teleflex Incorporated · Anesthesiology
Feb 2025
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K241451 is an FDA 510(k) clearance for the Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric), a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Teleflex Incorporated (Morrisville, US). The FDA issued a Cleared decision on February 11, 2025, 265 days after receiving the submission on May 22, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K241451 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2024
Decision Date February 11, 2025
Days to Decision 265 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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