Cleared Special

K123816 - DIGITAL ELECTROCARDIOGRAPHS

K123816 is an FDA 510(k) clearance for DIGITAL ELECTROCARDIOGRAPHS, manufactured by Shenzhen Biocare Electronics Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Special 510(k) pathway after a 77-day FDA review.

K123816 · Shenzhen Biocare Electronics Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
77d
Days
Class 2
Risk

K123816 is an FDA 510(k) clearance for the DIGITAL ELECTROCARDIOGRAPHS. 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 February 27, 2013 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Shenzhen Biocare Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K123816

510(k) Number K123816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2012
Decision Date February 27, 2013
Days to Decision 77 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

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
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