Cleared Traditional

K180253 - Sheridan Endobronchial Tubes

K180253 is an FDA 510(k) clearance for Sheridan Endobronchial Tubes, manufactured by Teleflex Medical. The device is a Class 2 Anesthesiology device with product code CBI cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K180253 · Teleflex Medical · Anesthesiology device
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Nov 2018
Decision
276d
Days
Class 2
Risk

K180253 is an FDA 510(k) clearance for the Sheridan Endobronchial Tubes. Classified as Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (product code CBI), Class II - Special Controls.

Submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on November 2, 2018 after a review of 276 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5740 - 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

FDA 510(k) Submission Details - K180253

510(k) Number K180253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2018
Decision Date November 02, 2018
Days to Decision 276 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
136d slower than avg
Panel avg: 140d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBI Device Classification - Class 2, Special Controls

Product Code CBI Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5740
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 - CBI Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)

All 19
Devices cleared under the same product code (CBI) and FDA review panel - the closest regulatory comparables to K180253.
Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable
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ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R
K200968 · Insung Medical Co., Ltd. · Dec 2020
VivaSight-DL System
K181886 · Etview , Ltd. · Nov 2018
5.0 Fr Arndt Endobronchial Blocker Set
K160542 · Cook Incorporated · Aug 2016
RUSCH ENDOBRONCHIAL TUBES
K141888 · Teleflexmedical, Inc. · Apr 2015
7.0 FR. ENDOBRONCHIAL BLOCKER
K021920 · Cook, Inc. · Aug 2002