Cleared Traditional

K173226 - CardiMax Electrocardiograph

K173226 is an FDA 510(k) clearance for CardiMax Electrocardiograph, manufactured by Fukuda Denshi USA, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K173226 · Fukuda Denshi USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Apr 2018
Decision
195d
Days
Class 2
Risk

K173226 is an FDA 510(k) clearance for the CardiMax Electrocardiograph. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Redmond, US). The FDA issued a Cleared decision on April 16, 2018 after a review of 195 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 Fukuda Denshi USA, Inc. devices

FDA 510(k) Submission Details - K173226

510(k) Number K173226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2017
Decision Date April 16, 2018
Days to Decision 195 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
70d slower than avg
Panel avg: 125d · This submission: 195d
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 417
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K173226.
physiQ Heart Rhythm Module
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CheckMyHeart Plus
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HeRO Symphony, HeRO ES, HeRO solo/duet
K180242 · Medical Predictive Science Corporation · Feb 2018
MiCor A100 Wearable ECG Recorder
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Electrocardiograph
K171942 · Edan Instruments, Inc. · Jan 2018