Cleared Traditional

K131819 - PC ECG

K131819 is an FDA 510(k) clearance for PC ECG, manufactured by Edan Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K131819 · Edan Instruments, Inc. · Cardiovascular device
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Nov 2013
Decision
155d
Days
Class 2
Risk

K131819 is an FDA 510(k) clearance for the PC ECG. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on November 22, 2013 after a review of 155 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 Edan Instruments, Inc. devices

FDA 510(k) Submission Details - K131819

510(k) Number K131819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2013
Decision Date November 22, 2013
Days to Decision 155 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
30d slower than avg
Panel avg: 125d · This submission: 155d
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 330
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K131819.
DIGITAL ELECTROCARDIOGRAPH
K131858 · Guangdong Biolight Meditech Co., Ltd. · Jun 2014
SE-601 SERIES ELECTROCARDIOGRAPH
K131503 · Edan Instruments, Inc. · Feb 2014
ALIVECOR HEART MONITOR OTC
K130921 · AliveCor, Inc. · Feb 2014
DIGITAL ELECTROCARDIOGRAPHS
K131262 · Sonoscape Company Limited · Nov 2013
PHILIPS DXL 12/16-LEAD ECG ALGORITHM
K132068 · Philips Medical Systems · Sep 2013
ALIVECOR HEART MONITOR
K130409 · AliveCor, Inc. · Sep 2013