Cleared Traditional

K171917 - Frova Intubating Introducer

K171917 is an FDA 510(k) clearance for Frova Intubating Introducer, manufactured by Cook Incorporated. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K171917 · Cook Incorporated · Anesthesiology device
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Apr 2018
Decision
300d
Days
Class 2
Risk

K171917 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 Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on April 23, 2018 after a review of 300 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. 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 Cook Incorporated devices

FDA 510(k) Submission Details - K171917

510(k) Number K171917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2017
Decision Date April 23, 2018
Days to Decision 300 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
160d slower than avg
Panel avg: 140d · This submission: 300d
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 131
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K171917.
Yikang Endotracheal Tube
K190213 · Jiangxi Yikang Medical Instrument Group Co., Ltd. · Sep 2019
Endotracheal Tube
K190274 · Tianjin Medis Medical Device Co., Ltd. · Jul 2019
VivaSight-SL (TVT) system
K181880 · Etview , Ltd. · Nov 2018
NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet
K172208 · Nevap, Inc. · Feb 2018
Endotracheal tube
K170234 · Zhanjiang Star Enterprise Co., Ltd. · Jan 2018
IRRIS (Infra-Red-Red Intubation System)
K171411 · A.R Guide IN Medical , Ltd. · Jan 2018