Cleared Traditional

K163607 - ECG Acquisition Systems

K163607 is an FDA 510(k) clearance for ECG Acquisition Systems, manufactured by Vales & Hills Biomedical Tech. , Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 359-day FDA review.

K163607 · Vales & Hills Biomedical Tech. , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
359d
Days
Class 2
Risk

K163607 is an FDA 510(k) clearance for the ECG Acquisition Systems. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Vales & Hills Biomedical Tech. , Ltd. (Beijing, CN). The FDA issued a Cleared decision on December 15, 2017 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K163607

510(k) Number K163607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2016
Decision Date December 15, 2017
Days to Decision 359 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
234d slower than avg
Panel avg: 125d · This submission: 359d
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 Consultant

Shenzhen Joyantech Consulting Co., Ltd.
Field Fu

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 475
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K163607.
Electrocardiograph
K171942 · Edan Instruments, Inc. · Jan 2018
CONTEC™ Electrocardiograph
K171360 · Contec Medical Systems Co.,Ltd · Jan 2018
Digital Electrocardiograph
K171517 · Biocare Bio-Medical Equipment Co., Ltd. · Jan 2018
Creavo Vitalscan Magnetocardiograph
K170154 · Creavo Medical Technologies, Ltd. · Oct 2017
Electrocardiograph
K171943 · Edan Instruments, Inc. · Sep 2017
CARDIOVIT FT-1
K170182 · Schiller AG · Jul 2017