Cleared Traditional

K161813 - Frova Intubating Introducer

K161813 is an FDA 510(k) clearance for Frova Intubating Introducer, manufactured by William Cook Europe Aps. 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.

K161813 · William Cook Europe Aps · Anesthesiology device
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May 2017
Decision
322d
Days
Class 2
Risk

K161813 is an FDA 510(k) clearance for the Frova Intubating Introducer. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by William Cook Europe Aps (Bjaeverskov, DK). The FDA issued a Cleared decision on May 19, 2017 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 William Cook Europe Aps devices

FDA 510(k) Submission Details - K161813

510(k) Number K161813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2016
Decision Date May 19, 2017
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 134
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K161813.
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Endotracheal tube
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K171411 · A.R Guide IN Medical , Ltd. · Jan 2018
Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye
K151381 · Covidien · Dec 2015
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K150603 · Teleflexmedical, Inc. · Nov 2015
TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT
K141939 · Teleflexmedical, Inc. · Nov 2014