Cleared Traditional

K011265 - ULTRASOUND TRANSDUCER COVER

K011265 is the FDA 510(k) clearance for ULTRASOUND TRANSDUCER COVER by Advance Medical Designs, Inc.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K011265 · Advance Medical Designs, Inc. · Radiology device
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Oct 2001
Decision
188d
Days
Class 2
Risk

K011265 is an FDA 510(k) clearance for the ULTRASOUND TRANSDUCER COVER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on October 30, 2001 after a review of 188 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 Advance Medical Designs, Inc. devices

Submission Details

510(k) Number K011265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2001
Decision Date October 30, 2001
Days to Decision 188 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 107d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 182
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