Cleared Traditional

K101876 - DIGITAL ELECTROCARDIOGRAPH

K101876 is an FDA 510(k) clearance for DIGITAL ELECTROCARDIOGRAPH, manufactured by Shenzhen Biocare Electronics Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K101876 · Shenzhen Biocare Electronics Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
238d
Days
Class 2
Risk

K101876 is an FDA 510(k) clearance for the DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Shenzhen Biocare Electronics Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 1, 2011 after a review of 238 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 Biocare Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K101876

510(k) Number K101876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2010
Decision Date March 01, 2011
Days to Decision 238 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 125d · This submission: 238d
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 270
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K101876.
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K102854 · Edan Instruments, Inc. · Dec 2010
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K102830 · Edan Instruments, Inc. · Dec 2010