Cleared Traditional

K082174 - Y-ADAPTER

K082174 is an FDA 510(k) clearance for Y-ADAPTER, manufactured by Asthmatx, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KTI cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K082174 · Asthmatx, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
80d
Days
Class 2
Risk

K082174 is an FDA 510(k) clearance for the Y-ADAPTER. Classified as Bronchoscope Accessory (product code KTI), Class II - Special Controls.

Submitted by Asthmatx, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 20, 2008 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Asthmatx, Inc. devices

FDA 510(k) Submission Details - K082174

510(k) Number K082174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2008
Decision Date October 20, 2008
Days to Decision 80 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 89d · This submission: 80d
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 24
Devices cleared under the same product code (KTI) and FDA review panel - the closest regulatory comparables to K082174.
Elation Pulmonary Balloon Dilation
K161392 · Merit Medical Systems, Inc. · Sep 2016
INSPIRA AIR BALLOON DILATION SYSTEM
K110218 · Acclarent, Inc. · Mar 2011
AIRWAY BALLOON CATHETER INFLATION DEVICE
K090660 · Acclarent, Inc. · Jun 2009
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350
K023337 · Boston Scientific Corp · Nov 2002
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210
K020765 · Boston Scientific Corp · Apr 2002