Cleared Traditional

K112858 - GENESIS TOUCH SYSTEM

K112858 is the FDA 510(k) clearance for GENESIS TOUCH SYSTEM by Honeywell Hommed, LLC. It is a Class 2 Cardiovascular device (product code DRG) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K112858 · Honeywell Hommed, LLC · Cardiovascular device
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Jan 2012
Decision
116d
Days
Class 2
Risk

K112858 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, LLC (Brookfield, US). The FDA issued a Cleared decision on January 24, 2012 after a review of 116 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.

View all Honeywell Hommed, LLC devices

Submission Details

510(k) Number K112858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date January 24, 2012
Days to Decision 116 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
9d faster than avg
Panel avg: 125d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

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