Cleared Traditional

K141747 - RHINOGUARD

K141747 is an FDA 510(k) clearance for RHINOGUARD, manufactured by Davis Medical. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K141747 · Davis Medical · Anesthesiology device
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Apr 2015
Decision
294d
Days
Class 2
Risk

K141747 is an FDA 510(k) clearance for the RHINOGUARD. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Davis Medical (Marana, US). The FDA issued a Cleared decision on April 20, 2015 after a review of 294 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 Davis Medical devices

FDA 510(k) Submission Details - K141747

510(k) Number K141747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2014
Decision Date April 20, 2015
Days to Decision 294 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
154d slower than avg
Panel avg: 140d · This submission: 294d
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 K141747.
IRRIS (Infra-Red-Red Intubation System)
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K141939 · Teleflexmedical, Inc. · Nov 2014
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KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE
K131254 · Kimberly-Clark Corp. · Aug 2013