Cleared Traditional

K112858 - GENESIS TOUCH SYSTEM

K112858 is an FDA 510(k) clearance for GENESIS TOUCH SYSTEM, manufactured by Honeywell Hommed, LLC. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K112858

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
Combination Product No
PCCP Authorized No
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.

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 134
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