Cleared Traditional

K241451 - Rusch Endotracheal Tubes (Reinforced)

Also marketed or referenced as:
Rusch Endotracheal Tubes (Safety Clear) Rusch Endotracheal Tubes (Safety Clear Pediatric)

K241451 is an FDA 510(k) clearance for Rusch Endotracheal Tubes (Reinforced), manufactured by Teleflex Incorporated. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K241451 · Teleflex Incorporated · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
265d
Days
Class 2
Risk

K241451 is an FDA 510(k) clearance for the Rusch Endotracheal Tubes (Reinforced). Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Teleflex Incorporated (Morrisville, US). The FDA issued a Cleared decision on February 11, 2025 after a review of 265 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 Incorporated devices

FDA 510(k) Submission Details - K241451

510(k) Number K241451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 140d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

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 136
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K241451.
Frova Intubating Introducer (C-CAE-14.0-70-FII)
K251499 · William Cook Europe Aps · Jun 2025
ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U)
K250243 · Flexicare Medical Limited. · May 2025
LMA Fastrach ETT SU
K242495 · Teleflex Medical · Apr 2025
Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)
K233341 · Covidien, LLC · May 2024
Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
K223130 · Covidien · Aug 2023
Wei Nasal Jet Tube
K211543 · Well Lead Medical Co., Ltd. · Jul 2022