Cleared Traditional

K151522 - DEFENDO Bronchoscopy Suction Valve

K151522 is an FDA 510(k) clearance for DEFENDO Bronchoscopy Suction Valve, manufactured by Medivators, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KTI cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K151522 · Medivators, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
104d
Days
Class 2
Risk

K151522 is an FDA 510(k) clearance for the DEFENDO Bronchoscopy Suction Valve. Classified as Bronchoscope Accessory (product code KTI), Class II - Special Controls.

Submitted by Medivators, Inc. (Conroe, US). The FDA issued a Cleared decision on September 17, 2015 after a review of 104 days - within the typical 510(k) review window.

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.

View all Medivators, Inc. devices

FDA 510(k) Submission Details - K151522

510(k) Number K151522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2015
Decision Date September 17, 2015
Days to Decision 104 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
14d slower than avg
Panel avg: 90d · This submission: 104d
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 K151522.
Elation Pulmonary Balloon Dilation
K161392 · Merit Medical Systems, Inc. · Sep 2016
Dillard Airway Dilatation System
K153484 · Intuit Medical Products, LLC · Jul 2016
ViziShot FLEX
K152922 · Spiration, Inc. · Feb 2016
aeris Balloon Dialation Catheter
K150951 · Bryan Medical, Inc. · Jun 2015
INSPIRA AIR BALLOON DILATION SYSTEM
K110218 · Acclarent, Inc. · Mar 2011
AIRWAY BALLOON CATHETER INFLATION DEVICE
K090660 · Acclarent, Inc. · Jun 2009