Cleared Traditional

K040213 - MHLX7EC TRANSDUCER

K040213 is an FDA 510(k) clearance for MHLX7EC TRANSDUCER, manufactured by Microhelix, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K040213 · Microhelix, Inc. · Radiology device
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Sep 2004
Decision
236d
Days
Class 2
Risk

K040213 is an FDA 510(k) clearance for the MHLX7EC TRANSDUCER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Microhelix, Inc. (Bainbridge Island, US). The FDA issued a Cleared decision on September 22, 2004 after a review of 236 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 Microhelix, Inc. devices

FDA 510(k) Submission Details - K040213

510(k) Number K040213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2004
Decision Date September 22, 2004
Days to Decision 236 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 107d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 312
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