Cleared Traditional

K140472 - BONASTENT TRACHEAL / BRONCHIAL

K140472 is an FDA 510(k) clearance for BONASTENT TRACHEAL / BRONCHIAL, manufactured by Endochoice, Inc.. The device is a Class 2 Anesthesiology device with product code JCT cleared through the Traditional 510(k) pathway after a 234-day FDA review.

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

FDA 510(k) Submission Details - K140472

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
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.

JCT Device Classification - Class 2, Special Controls

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 29
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