Cleared Traditional

K121628 - EPI MINI ECG PORTABLE HEALTH MONITORING...

K121628 is an FDA 510(k) clearance for EPI MINI ECG PORTABLE HEALTH MONITORING..., manufactured by Epi Mobile Health Solutions (S) Pte, Ltd.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 386-day FDA review.

K121628 · Epi Mobile Health Solutions (S) Pte, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
386d
Days
Class 2
Risk

K121628 is an FDA 510(k) clearance for the EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI). Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Epi Mobile Health Solutions (S) Pte, Ltd. (Washington, US). The FDA issued a Cleared decision on June 25, 2013 after a review of 386 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 Epi Mobile Health Solutions (S) Pte, Ltd. devices

FDA 510(k) Submission Details - K121628

510(k) Number K121628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2012
Decision Date June 25, 2013
Days to Decision 386 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
261d slower than avg
Panel avg: 125d · This submission: 386d
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 117
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