Cleared Traditional

K101952 - KONIX ULTRASOUND GEL

K101952 is an FDA 510(k) clearance for KONIX ULTRASOUND GEL, manufactured by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K101952 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · Radiology device
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May 2011
Decision
319d
Days
Class 2
Risk

K101952 is an FDA 510(k) clearance for the KONIX ULTRASOUND GEL. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa (Zephyr Cove, US). The FDA issued a Cleared decision on May 27, 2011 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa devices

FDA 510(k) Submission Details - K101952

510(k) Number K101952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2010
Decision Date May 27, 2011
Days to Decision 319 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
212d slower than avg
Panel avg: 107d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

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 240
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K101952.
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