Cleared Traditional

K140017 - TRANSONIC HCM 102 SYSTEM (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K140017 · Transonic Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
257d
Days
Class 2
Risk

K140017 is an FDA 510(k) clearance for the TRANSONIC HCM 102 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 September 16, 2014 after a review of 257 days - an extended review cycle.

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. Standard predicate reliance. 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 K140017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2014
Decision Date September 16, 2014
Days to Decision 257 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
132d slower than avg
Panel avg: 125d · This submission: 257d
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 176
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K140017.
Argos Infinity (Rev. 1.0)
K253092 · Retia Medical Systems, Inc. · Feb 2026
VitalStream ART Connect
K251275 · Caretaker Medical · Sep 2025
Cogent™ Hemodynamic Monitoring System
K232048 · Icu Medical · Dec 2023
Hypotension Decision Assist Model HDA-OR2
K212529 · Directed Systems, Ltd. · Nov 2021
PulsioFlex Monitoring System with ProAQT Sensor
K192169 · Pulsion Medical Systems SE · Apr 2020
EV1000 Clinical Platform
K193179 · Edwards Lifesciences, LLC · Dec 2019