Cleared Traditional

K090743 - YIELD MINI DOPPLER SYSTEM

K090743 is an FDA 510(k) clearance for YIELD MINI DOPPLER SYSTEM, manufactured by Broncus Technologies, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K090743 · Broncus Technologies, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
14d
Days
Class 2
Risk

K090743 is an FDA 510(k) clearance for the YIELD MINI DOPPLER SYSTEM. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Broncus Technologies, Inc. (Mountain View, US). The FDA issued a Cleared decision on April 3, 2009 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight 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 Broncus Technologies, Inc. devices

FDA 510(k) Submission Details - K090743

510(k) Number K090743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2009
Decision Date April 03, 2009
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 795
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K090743.
APLIO MX SSA-780A, VERSION 1.0
K092948 · Toshiba America Medical Systems, In.C · Oct 2009
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001
K092179 · Toshiba America Medical Systems, In.C · Jul 2009
MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150
K091009 · Esaote, S.P.A. · May 2009
ACUSON P50 ULTRASOUND SYSTEM
K083114 · Siemens Medical Solutions USA, Inc. · Mar 2009
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K090334 · Siemens Medi Cal Solutions, Inc. · Feb 2009
APLIO ARTIDA V2.0 SSH-880CV
K090158 · Toshiba America Medical Systems, In.C · Feb 2009