Cleared Special

K101242 - GENESIS DM MODEL: 6053000A1

K101242 is an FDA 510(k) clearance for GENESIS DM MODEL: 6053000A1, manufactured by Honeywell Hommed, LLC. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Special 510(k) pathway after a 39-day FDA review.

K101242 · Honeywell Hommed, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
39d
Days
Class 2
Risk

K101242 is an FDA 510(k) clearance for the GENESIS DM MODEL: 6053000A1. 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 June 11, 2010 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Honeywell Hommed, LLC devices

FDA 510(k) Submission Details - K101242

510(k) Number K101242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2010
Decision Date June 11, 2010
Days to Decision 39 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 125d · This submission: 39d
Pathway characteristics
Modification to existing cleared device.

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 135
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K101242.
WALDO PATIENT MONITOR
K110334 · Waldo Health · Apr 2011
INTEL HEALTH GUIDE
K103276 · Intel Corporation Digital Health Group · Feb 2011
3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM
K101834 · 3M Company · Sep 2010
FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY
K100427 · Taidoc Technology Corporation · May 2010
SAVI WIRELESS, MODEL PM500
K091696 · Medicomp, Inc. · Oct 2009
HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM
K090610 · Hospira, Inc. · Mar 2009