Cleared Traditional

K113485 - ELECTROCARDIOGRAPH

K113485 is an FDA 510(k) clearance for ELECTROCARDIOGRAPH, manufactured by Shenzhen Carewell Electronics Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K113485 · Shenzhen Carewell Electronics Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
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Apr 2012
Decision
154d
Days
Class 2
Risk

K113485 is an FDA 510(k) clearance for the ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Shenzhen Carewell Electronics Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on April 25, 2012 after a review of 154 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 Shenzhen Carewell Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K113485

510(k) Number K113485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2011
Decision Date April 25, 2012
Days to Decision 154 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
29d slower than avg
Panel avg: 125d · This submission: 154d
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 403
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K113485.
RSCRIBE ELECTROCARDIOGRAPH
K120865 · Mortara Instrument, Inc. · Jul 2012
CARDIO 7
K113306 · Bionet Co., Ltd. · Jul 2012
HEARTCHECK ECG PEN WITH GEMS HOME
K121009 · Cardiocomm Solutions, Inc. · May 2012
PAGEWRITER TC 20, 30, 50, 70
K113144 · Philips Medical Systems · Apr 2012
ELECTROCARDIOGRAPH
K120188 · Edan Instruments, Inc. · Mar 2012
CALG-STR EXERCISE ECG ANALYSIS ALGORITHM
K112959 · Philips Health Care · Jan 2012