Cleared Traditional

CheckMyHeart Plus (K172778) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172778 · Dailycare Biomedical, Inc. · Cardiovascular device
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Jul 2018
Decision
294d
Days
Class 2
Risk

K172778 is an FDA 510(k) clearance for the CheckMyHeart Plus. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Dailycare Biomedical, Inc. (Taoyuan City Taoyuan, TW). The FDA issued a Cleared decision on July 5, 2018 after a review of 294 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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. Standard predicate reliance. 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 Dailycare Biomedical, Inc. devices

Submission Details

510(k) Number K172778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2017
Decision Date July 05, 2018
Days to Decision 294 days
Submission Type Traditional
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
169d slower than avg
Panel avg: 125d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 146
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K172778.
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