Cleared Traditional

K172778 - CheckMyHeart Plus

K172778 is an FDA 510(k) clearance for CheckMyHeart Plus, manufactured by Dailycare Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 294-day FDA review.

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

FDA 510(k) Submission Details - K172778

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.

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 305
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K172778.
MAC VU360 Resting ECG Analysis System
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Universal SmartECG
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physiQ Heart Rhythm Module
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Kenz Cardico1211
K172068 · Suzuken Co., Ltd. · Jun 2018
CardiMax Electrocardiograph
K173226 · Fukuda Denshi USA, Inc. · Apr 2018
HeRO Symphony, HeRO ES, HeRO solo/duet
K180242 · Medical Predictive Science Corporation · Feb 2018