Cleared Traditional

CardiMax Electrocardiograph (K173226) - FDA 510(k) Clearance

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

K173226 · Fukuda Denshi USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 80
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K173226.
physiQ Heart Rhythm Module
K180234 · Physiq, Inc. · Aug 2018
CheckMyHeart Plus
K172778 · Dailycare Biomedical, Inc. · Jul 2018
Kenz Cardico1211
K172068 · Suzuken Co., Ltd. · Jun 2018
HeRO Symphony, HeRO ES, HeRO solo/duet
K180242 · Medical Predictive Science Corporation · Feb 2018
MiCor A100 Wearable ECG Recorder
K162665 · Mitac International Corp. · Jan 2018
Electrocardiograph
K171942 · Edan Instruments, Inc. · Jan 2018