Cleared Traditional

K100402 - SITE-RITE VISION ULTRASOUND SYSTEM

K100402 is an FDA 510(k) clearance for SITE-RITE VISION ULTRASOUND SYSTEM, manufactured by Bard Access Systems, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K100402 · Bard Access Systems, Inc. · Radiology device
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Mar 2010
Decision
17d
Days
Class 2
Risk

K100402 is an FDA 510(k) clearance for the SITE-RITE VISION ULTRASOUND 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 Bard Access Systems, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on March 5, 2010 after a review of 17 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 Bard Access Systems, Inc. devices

FDA 510(k) Submission Details - K100402

510(k) Number K100402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date March 05, 2010
Days to Decision 17 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 107d · This submission: 17d
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 Consultant

Citech
ROBERT MOSENKIN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

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