Cleared Traditional

K050785 - AMSINO ENDOTRACHEAL TUBE

K050785 is an FDA 510(k) clearance for AMSINO ENDOTRACHEAL TUBE, manufactured by Amsino International, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K050785 · Amsino International, Inc. · Anesthesiology device
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Jul 2005
Decision
109d
Days
Class 2
Risk

K050785 is an FDA 510(k) clearance for the AMSINO ENDOTRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on July 15, 2005 after a review of 109 days - within the typical 510(k) review window.

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 - K050785

510(k) Number K050785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2005
Decision Date July 15, 2005
Days to Decision 109 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 140d · This submission: 109d
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 204
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K050785.
ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES
K060094 · Arcadia Medical Corporation · May 2006
LMA FASTRACH ETT SINGLE USE
K051993 · The Laryngeal Mask Co., Ltd. · Dec 2005
TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM
K052233 · Etview , Ltd. · Dec 2005
PEDIATRIC CUFFED AND UNCUFFED ET TUBES
K050803 · Vitaid, Ltd. · Jun 2005
TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)
K041311 · Tiger Medical Products, Ltd. · Mar 2005
WELL LEAD ENDOTRACHEAL TUBE
K042683 · Well Lead Medical Instruments · Feb 2005