Cleared Special

Digital Electrocardiograph (K171517) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K171517 · Biocare Bio-Medical Equipment Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
232d
Days
Class 2
Risk

K171517 is an FDA 510(k) clearance for the Digital Electrocardiograph. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Biocare Bio-Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 11, 2018 after a review of 232 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biocare Bio-Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K171517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2017
Decision Date January 11, 2018
Days to Decision 232 days
Submission Type Special
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
107d slower than avg
Panel avg: 125d · This submission: 232d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DPS Electrocardiograph

All 146
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K171517.
MiCor A100 Wearable ECG Recorder
K162665 · Mitac International Corp. · Jan 2018
Electrocardiograph
K171942 · Edan Instruments, Inc. · Jan 2018
CONTEC™ Electrocardiograph
K171360 · Contec Medical Systems Co.,Ltd · Jan 2018
Electrocardiograph
K171943 · Edan Instruments, Inc. · Sep 2017
Electrocardiograph
K170995 · Edan Instruments, Inc. · Jun 2017
PC ECG
K160876 · Edan Instruments, Inc. · Feb 2017