Cleared Traditional

K131819 - PC ECG

K131819 is the FDA 510(k) clearance for PC ECG by Edan Instruments, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 175
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K131819.
PC ECG
K161302 · Edan Instruments, Inc. · Jul 2016
PC ECG
K152427 · Edan Instruments, Inc. · Feb 2016
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K131503 · Edan Instruments, Inc. · Feb 2014
PHILIPS DXL 12/16-LEAD ECG ALGORITHM
K132068 · Philips Medical Systems · Sep 2013
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K120770 · Ge Medical Systems Information Technologies · Dec 2012