Cleared Traditional

K141792 - GENESIS TOUCH SYSTEM

K141792 is an FDA 510(k) clearance for GENESIS TOUCH SYSTEM, manufactured by Honeywell Hommed. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K141792 · Honeywell Hommed · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
146d
Days
Class 2
Risk

K141792 is an FDA 510(k) clearance for the GENESIS TOUCH SYSTEM. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Honeywell Hommed (Brookfield, US). The FDA issued a Cleared decision on November 25, 2014 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - 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.

FDA 510(k) Submission Details - K141792

510(k) Number K141792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2014
Decision Date November 25, 2014
Days to Decision 146 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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 - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 187
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K141792.
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K150289 · Cardioline S.P.A · Aug 2015
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K141020 · Mortara Instrument, Inc. · Dec 2014
LG SMARTHEALTH
K133997 · Lg Electronics · Nov 2014
ECARE COORDINATOR (ECC)
K141706 · Visicu, Inc. · Sep 2014
VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)
K141167 · Vitalconnect, Inc. · Jul 2014
K141792 · GENESIS TOUCH SYSTEM
Download PDF FDA Summary Honeywell Hommed