Cleared Traditional

K163679 - Digital Automatic Blood Pressure Monitor MD3600

K163679 is an FDA 510(k) clearance for Digital Automatic Blood Pressure Monito..., manufactured by Grandway Technology (Shenzhen) Limited. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K163679 · Grandway Technology (Shenzhen) Limited · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
162d
Days
Class 2
Risk

K163679 is an FDA 510(k) clearance for the Digital Automatic Blood Pressure Monitor MD3600. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Grandway Technology (Shenzhen) Limited (Shenzhen, CN). The FDA issued a Cleared decision on June 7, 2017 after a review of 162 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 Grandway Technology (Shenzhen) Limited devices

FDA 510(k) Submission Details - K163679

510(k) Number K163679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2016
Decision Date June 07, 2017
Days to Decision 162 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
37d slower than avg
Panel avg: 125d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 840
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K163679.
Fully Automatic Blood Pressure Monitor
K171282 · Andon Health Co, Ltd. · Jul 2017
Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series
K163648 · Grandway Technology (Shenzhen) Limited · Jul 2017
TONOPORT VI
K170966 · Par Medizintechnik GmbH & Co. KG · Jun 2017
Matrix Data Management System
K162463 · Global Instrumentation, LLC · May 2017
A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor
K170196 · A&D Company, Ltd. · May 2017
Fully Automatic Electronic Blood Pressure Monitor
K163276 · Andon Health Co, Ltd. · May 2017