Cleared Traditional

K190274 - Endotracheal Tube

K190274 is an FDA 510(k) clearance for Endotracheal Tube, manufactured by Tianjin Medis Medical Device Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K190274 · Tianjin Medis Medical Device Co., Ltd. · Anesthesiology device
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Jul 2019
Decision
172d
Days
Class 2
Risk

K190274 is an FDA 510(k) clearance for the Endotracheal Tube. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Tianjin Medis Medical Device Co., Ltd. (Tainjin, CN). The FDA issued a Cleared decision on July 30, 2019 after a review of 172 days - an extended review cycle.

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. 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 Tianjin Medis Medical Device Co., Ltd. devices

FDA 510(k) Submission Details - K190274

510(k) Number K190274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2019
Decision Date July 30, 2019
Days to Decision 172 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
32d slower than avg
Panel avg: 140d · This submission: 172d
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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K190274.
Sheridan Spiral-Flex Endotracheal Tubes
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K190213 · Jiangxi Yikang Medical Instrument Group Co., Ltd. · Sep 2019
VivaSight-SL (TVT) system
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Frova Intubating Introducer
K171917 · Cook Incorporated · Apr 2018
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K172208 · Nevap, Inc. · Feb 2018