Cleared Traditional

K190213 - Yikang Endotracheal Tube

K190213 is an FDA 510(k) clearance for Yikang Endotracheal Tube, manufactured by Jiangxi Yikang Medical Instrument Group Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K190213 · Jiangxi Yikang Medical Instrument Group Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
214d
Days
Class 2
Risk

K190213 is an FDA 510(k) clearance for the Yikang Endotracheal Tube. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Jiangxi Yikang Medical Instrument Group Co., Ltd. (Nanchang, CN). The FDA issued a Cleared decision on September 6, 2019 after a review of 214 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.

FDA 510(k) Submission Details - K190213

510(k) Number K190213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2019
Decision Date September 06, 2019
Days to Decision 214 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
74d slower than avg
Panel avg: 140d · This submission: 214d
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 241
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K190213.
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VivaSight-SL (TVT) system
K181880 · Etview , Ltd. · Nov 2018
Frova Intubating Introducer
K171917 · Cook Incorporated · Apr 2018
K190213 · Yikang Endotracheal Tube
Download PDF FDA Summary Jiangxi Yikang Medica…