Cleared Traditional

K134051 - TRANSONIC ELSA SYSTEM

K134051 is the FDA 510(k) clearance for TRANSONIC ELSA SYSTEM by Transonic Systems, Inc.. It is a Class 2 Cardiovascular device (product code DXG) cleared through the Traditional 510(k) pathway after a 394-day FDA review.

K134051 · Transonic Systems, Inc. · Cardiovascular device
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Jan 2015
Decision
394d
Days
Class 2
Risk

K134051 is an FDA 510(k) clearance for the TRANSONIC ELSA SYSTEM. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Transonic Systems, Inc. (Ithaca, US). The FDA issued a Cleared decision on January 29, 2015 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - the FDA cardiovascular device 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Transonic Systems, Inc. devices

Submission Details

510(k) Number K134051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2013
Decision Date January 29, 2015
Days to Decision 394 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 125d · This submission: 394d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 52
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