Cleared Special

K062469 - VOYAGER 12

K062469 is an FDA 510(k) clearance for VOYAGER 12, manufactured by Del Mar Reynolds Medical, Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Special 510(k) pathway after a 71-day FDA review.

K062469 · Del Mar Reynolds Medical, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
71d
Days
Class 2
Risk

K062469 is an FDA 510(k) clearance for the VOYAGER 12. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Del Mar Reynolds Medical, Ltd. (Hasbrouck Heights, US). The FDA issued a Cleared decision on November 3, 2006 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Del Mar Reynolds Medical, Ltd. devices

FDA 510(k) Submission Details - K062469

510(k) Number K062469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2006
Decision Date November 03, 2006
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 351
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