Cleared Traditional

K223130 - Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)

K223130 is an FDA 510(k) clearance for Shiley Pediatric Oral/Nasal Endotrachea..., manufactured by Covidien. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K223130 · Covidien · Anesthesiology device
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Aug 2023
Decision
331d
Days
Class 2
Risk

K223130 is an FDA 510(k) clearance for the Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEH.... Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on August 30, 2023 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

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

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FDA 510(k) Submission Details - K223130

510(k) Number K223130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2022
Decision Date August 30, 2023
Days to Decision 331 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
191d slower than avg
Panel avg: 140d · This submission: 331d
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 174
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K223130.
LMA Fastrach ETT SU
K242495 · Teleflex Medical · Apr 2025
Rusch Endotracheal Tubes (Reinforced)
K241451 · Teleflex Incorporated · Feb 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
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K200761 · Bryan Medical, Inc. · Nov 2020