Cleared Traditional

K162729 - Aintree Intubation Catheter

K162729 is an FDA 510(k) clearance for Aintree Intubation Catheter, manufactured by Cook Incorporated. The device is a Class 1 Anesthesiology device with product code BSR cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K162729 · Cook Incorporated · Anesthesiology device
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Aug 2017
Decision
316d
Days
Class 1
Risk

K162729 is an FDA 510(k) clearance for the Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway .... Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on August 11, 2017 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5790 - 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 Cook Incorporated devices

FDA 510(k) Submission Details - K162729

510(k) Number K162729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2016
Decision Date August 11, 2017
Days to Decision 316 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
176d slower than avg
Panel avg: 140d · This submission: 316d
Pathway characteristics
Predicate-based equivalence.

BSR Device Classification - Class 1, General Controls

Product Code BSR Stylet, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5790
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BSR Stylet, Tracheal Tube

All 12
Devices cleared under the same product code (BSR) and FDA review panel - the closest regulatory comparables to K162729.
RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
K955238 · Rusch Intl. · Feb 1996
RUSCH ENDOTRACHEAL TUBE STYLET
K952100 · Rusch, Inc. · Aug 1995
AUGUSTINE STYLET
K920468 · Augustine Medical, Inc. · Apr 1992
AUGUSTINE GUIDE(TM) KIT
K912690 · Augustine Medical, Inc. · Sep 1991
AUGUSTINE STYLET
K910659 · Augustine Medical, Inc. · May 1991
STYLET TRACHAEL TUBE
K905133 · Medical Devices, Inc. · Apr 1991