Cleared Special

K062397 - SENTINEL

K062397 is an FDA 510(k) clearance for SENTINEL, manufactured by Del Mar Reynolds Medical, Ltd.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Special 510(k) pathway after a 162-day FDA review.

K062397 · Del Mar Reynolds Medical, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
162d
Days
Class 2
Risk

K062397 is an FDA 510(k) clearance for the SENTINEL. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Del Mar Reynolds Medical, Ltd. (Hasbrouck Heights, US). The FDA issued a Cleared decision on January 25, 2007 after a review of 162 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K062397

510(k) Number K062397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2006
Decision Date January 25, 2007
Days to Decision 162 days
Submission Type Special
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
37d slower than avg
Panel avg: 125d · This submission: 162d
Pathway characteristics
Modification to existing cleared device.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 284
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K062397.
HEARTEVENT, MODEL AT
K072385 · Diagnostic Devices Pty, Ltd. · Jan 2008
FIDELITY 200 CARDIAC EVENT RECORDER
K071228 · Signalife, Inc. · Nov 2007
RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER
K063609 · Shl Telemedicine International , Ltd. · Sep 2007
TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +
K061780 · Rozinn Electronics, Inc. · Sep 2006
CG-6108 ARRHYTHMIA ECG EVENT RECORDER
K060911 · Card Guard Scientific Survival , Ltd. · Aug 2006
PEPER
K060297 · Medical Monitors, Ltd. · Aug 2006
K062397 · SENTINEL
Download PDF FDA Summary Del Mar Reynolds Medi…