Cleared Traditional

K140472 - BONASTENT TRACHEAL / BRONCHIAL (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K140472 · Endochoice, Inc. · Anesthesiology device
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Oct 2014
Decision
234d
Days
Class 2
Risk

K140472 is an FDA 510(k) clearance for the BONASTENT TRACHEAL / BRONCHIAL. Classified as Prosthesis, Tracheal, Expandable (product code JCT), Class II - Special Controls.

Submitted by Endochoice, Inc. (Toronto, CA). The FDA issued a Cleared decision on October 17, 2014 after a review of 234 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 878.3720 - 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 Endochoice, Inc. devices

Submission Details

510(k) Number K140472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2014
Decision Date October 17, 2014
Days to Decision 234 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 139d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JCT Prosthesis, Tracheal, Expandable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3720
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 - JCT Prosthesis, Tracheal, Expandable

All 44
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