Cleared Special

K062007 - DMS 300-7

K062007 is an FDA 510(k) clearance for DMS 300-7, manufactured by Diagnostic Monitoring Software. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Special 510(k) pathway after a 30-day FDA review.

K062007 · Diagnostic Monitoring Software · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
30d
Days
Class 2
Risk

K062007 is an FDA 510(k) clearance for the DMS 300-7. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Diagnostic Monitoring Software (Stateline, US). The FDA issued a Cleared decision on August 16, 2006 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 Diagnostic Monitoring Software devices

FDA 510(k) Submission Details - K062007

510(k) Number K062007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2006
Decision Date August 16, 2006
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 88
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K062007.
ZIO PATCH
K113862 · iRhythm Technologies, Inc. · Feb 2012
KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER
K111745 · Card Guard Scientific Survival , Ltd. · Aug 2011
ZIO PATCH, MODEL Z100
K090363 · iRhythm Technologies, Inc. · May 2009
H12+ HOLTER RECORDER
K050896 · Mortara Instrument, Inc. · Aug 2005
PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A
K032103 · Philips Medical Systems · Jul 2003
KING OF HEARTS EXPRESS + AF MONITOR
K020825 · Card Guard Scientific Survival , Ltd. · Apr 2002