Cleared Traditional

K130878 - CLOUDEKG

K130878 is an FDA 510(k) clearance for CLOUDEKG, manufactured by Makromed, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 371-day FDA review.

K130878 · Makromed, Inc. · Cardiovascular device
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Apr 2014
Decision
371d
Days
Class 2
Risk

K130878 is an FDA 510(k) clearance for the CLOUDEKG. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Makromed, Inc. (Salem, US). The FDA issued a Cleared decision on April 4, 2014 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Makromed, Inc. devices

FDA 510(k) Submission Details - K130878

510(k) Number K130878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2013
Decision Date April 04, 2014
Days to Decision 371 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
246d slower than avg
Panel avg: 125d · This submission: 371d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 125
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