Cleared Traditional

K233341 - Shiley Oral/Nasal Endotracheal Tube Int...

K233341 is the FDA 510(k) clearance for Shiley Oral/Nasal Endotracheal Tube Int... by Covidien, LLC. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K233341 · Covidien, LLC · Anesthesiology device
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May 2024
Decision
234d
Days
Class 2
Risk

K233341 is an FDA 510(k) clearance for the Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 8743.... Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on May 20, 2024 after a review of 234 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 Covidien, LLC devices

Submission Details

510(k) Number K233341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date May 20, 2024
Days to Decision 234 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
94d slower than avg
Panel avg: 140d · This submission: 234d
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
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K233341.
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
Rusch Endotracheal Tubes (Reinforced)
K241451 · Teleflex Incorporated · Feb 2025
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
Tenax Laser Resistant Endotracheal Tube
K213028 · Bryan Medical, Inc. · Oct 2021