Cleared Special

K251499 - Frova Intubating Introducer (C-CAE-14.0-70-FII) (FDA 510(k) Clearance)

Also includes:

Frova Intubating Introducer (C-CAE-14.0-70-FI) Frova Intubating Introducer (C-CAE-14.0-70-FIC) Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251499 · William Cook Europe Aps · Anesthesiology device

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Optimized for regulatory review, auditing and printing

Jun 2025

Decision

27d

Days

Class 2

Risk

K251499 is an FDA 510(k) clearance for the Frova Intubating Introducer (C-CAE-14.0-70-FII). 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 June 11, 2025 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number	K251499 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 15, 2025
Decision Date	June 11, 2025
Days to Decision	27 days
Submission Type	Special
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

112d faster than avg

Panel avg: 139d · This submission: 27d

Pathway characteristics

Modification to existing cleared device.

Device Classification

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.