Cleared Traditional

K140228 - DISPOSABLE TRACHEAL TUBE

K140228 is an FDA 510(k) clearance for DISPOSABLE TRACHEAL TUBE, manufactured by Suzhou Weikang Medical Apparatus Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K140228 · Suzhou Weikang Medical Apparatus Co., Ltd. · Anesthesiology device
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Dec 2014
Decision
322d
Days
Class 2
Risk

K140228 is an FDA 510(k) clearance for the DISPOSABLE TRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Suzhou Weikang Medical Apparatus Co., Ltd. (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on December 18, 2014 after a review of 322 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.

View all Suzhou Weikang Medical Apparatus Co., Ltd. devices

FDA 510(k) Submission Details - K140228

510(k) Number K140228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2014
Decision Date December 18, 2014
Days to Decision 322 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
182d slower than avg
Panel avg: 140d · This submission: 322d
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 150
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K140228.
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KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE
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