Not Cleared Direct

DEN170055 - Retrograde Intubation Set (FDA 510(k) Clearance)

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

DEN170055 · Cook Incorporated · Anesthesiology device
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Dec 2018
Decision
443d
Days
Class 2
Risk

DEN170055 is an FDA 510(k) submission (not cleared) for the Retrograde Intubation Set. Classified as Retrograde Intubation Set (product code QCX), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Not Cleared (DENG) decision on December 12, 2018 after a review of 443 days.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5095 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 443 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Cook Incorporated devices

Submission Details

510(k) Number DEN170055 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 25, 2017
Decision Date December 12, 2018
Days to Decision 443 days
Submission Type Direct
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
304d slower than avg
Panel avg: 139d · This submission: 443d
Pathway characteristics

Device Classification

Product Code QCX Retrograde Intubation Set
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5095
Definition A Retrograde Intubation Device Is A Prescription Device Used To Perform Retrograde Intubation Via The Cricothyroid Membrane. The Device May Contain Or Be Labeled For Use With Guidewires And Intubating Catheters, In Addition To Needles (21 Cfr 8685090), Syringe (21 Cfr 880.5860), And Hemostats (21 Cfr 878.4800).
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.