Cleared Abbreviated

K090214 - VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND

K090214 is an FDA 510(k) clearance for VERATHON INC. BLADDERSCAN BVM 9500 ULTR..., manufactured by Verathon Incorporated. The device is a Class 2 Radiology device with product code IYO cleared through the Abbreviated 510(k) pathway after a 43-day FDA review.

K090214 · Verathon Incorporated · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
43d
Days
Class 2
Risk

K090214 is an FDA 510(k) clearance for the VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Verathon Incorporated (Bothell, US). The FDA issued a Cleared decision on March 13, 2009 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K090214

510(k) Number K090214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2009
Decision Date March 13, 2009
Days to Decision 43 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Standards-based clearance path.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 897
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K090214 · VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND
Download PDF FDA Summary Verathon Incorporated