Cleared Traditional

K132335 - ULTRASOUND SCANNER FLEX FOCUS 1202

K132335 is an FDA 510(k) clearance for ULTRASOUND SCANNER FLEX FOCUS 1202, manufactured by B-K Medical Aps. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K132335 · B-K Medical Aps · Radiology device
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Jan 2014
Decision
168d
Days
Class 2
Risk

K132335 is an FDA 510(k) clearance for the ULTRASOUND SCANNER FLEX FOCUS 1202. 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 B-K Medical Aps (Herlev, DK). The FDA issued a Cleared decision on January 10, 2014 after a review of 168 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all B-K Medical Aps devices

FDA 510(k) Submission Details - K132335

510(k) Number K132335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2013
Decision Date January 10, 2014
Days to Decision 168 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 107d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
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