Cleared Special

K051960 - CARDIONAVIGATOR +

K051960 is an FDA 510(k) clearance for CARDIONAVIGATOR +, 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 31-day FDA review.

K051960 · 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
Aug 2005
Decision
31d
Days
Class 2
Risk

K051960 is an FDA 510(k) clearance for the CARDIONAVIGATOR +. 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 August 19, 2005 after a review of 31 days - a notably fast clearance 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. 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.

FDA 510(k) Submission Details - K051960

510(k) Number K051960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2005
Decision Date August 19, 2005
Days to Decision 31 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
94d faster than avg
Panel avg: 125d · This submission: 31d
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
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K051960 · CARDIONAVIGATOR +
Download PDF FDA Summary Del Mar Reynolds Medi…