Cleared Traditional

K153484 - Dillard Airway Dilatation System

K153484 is an FDA 510(k) clearance for Dillard Airway Dilatation System, manufactured by Intuit Medical Products, LLC. The device is a Class 2 Ear, Nose, Throat device with product code KTI cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K153484 · Intuit Medical Products, LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
237d
Days
Class 2
Risk

K153484 is an FDA 510(k) clearance for the Dillard Airway Dilatation System. Classified as Bronchoscope Accessory (product code KTI), Class II - Special Controls.

Submitted by Intuit Medical Products, LLC (Sugar Hill, US). The FDA issued a Cleared decision on July 27, 2016 after a review of 237 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K153484

510(k) Number K153484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2015
Decision Date July 27, 2016
Days to Decision 237 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 90d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTI Device Classification - Class 2, Special Controls

Product Code KTI Bronchoscope Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - KTI Bronchoscope Accessory

All 32
Devices cleared under the same product code (KTI) and FDA review panel - the closest regulatory comparables to K153484.
CRE Pulmonary Balloon Dilatation Catheter
K170759 · Boston Scientific Corporation · Jun 2017
ViziShot 2 FLEX
K163469 · Olympus Surgical Technologies America · Apr 2017
Elation Pulmonary Balloon Dilation
K161392 · Merit Medical Systems, Inc. · Sep 2016
ViziShot FLEX
K152922 · Spiration, Inc. · Feb 2016
DEFENDO Bronchoscopy Suction Valve
K151522 · Medivators, Inc. · Sep 2015
aeris Balloon Dialation Catheter
K150951 · Bryan Medical, Inc. · Jun 2015
K153484 · Dillard Airway Dilatation System
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