Cleared Traditional

K170954 - Portable ECG Monitor

K170954 is an FDA 510(k) clearance for Portable ECG Monitor, manufactured by Contec Medical Systems Co.,Ltd. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K170954 · Contec Medical Systems Co.,Ltd · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
60d
Days
Class 2
Risk

K170954 is an FDA 510(k) clearance for the Portable ECG Monitor. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Contec Medical Systems Co.,Ltd (Qinhuangdao, CN). The FDA issued a Cleared decision on May 30, 2017 after a review of 60 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Contec Medical Systems Co.,Ltd devices

FDA 510(k) Submission Details - K170954

510(k) Number K170954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2017
Decision Date May 30, 2017
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
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 280
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K170954.
Digital Electrocardiograph
K171517 · Biocare Bio-Medical Equipment 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
PC ECG
K161302 · Edan Instruments, Inc. · Jul 2016
PC ECG
K152427 · Edan Instruments, Inc. · Feb 2016