Cleared Traditional

K163648 - Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series

K163648 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 196-day FDA review.

K163648 · Grandway Technology (Shenzhen) Limited · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
196d
Days
Class 2
Risk

K163648 is an FDA 510(k) clearance for the Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Bloo.... 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 July 7, 2017 after a review of 196 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 - K163648

510(k) Number K163648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2016
Decision Date July 07, 2017
Days to Decision 196 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
71d slower than avg
Panel avg: 125d · This submission: 196d
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 K163648.
BP5S Wireless Blood Pressure Monitor
K171062 · Andon Health Co, Ltd. · Aug 2017
Electronic Blood Pressure Monitor
K161845 · Shenzhen Pango Electronic Co., Ltd. · Jul 2017
Fully Automatic Blood Pressure Monitor
K171282 · Andon Health Co, Ltd. · Jul 2017
TONOPORT VI
K170966 · Par Medizintechnik GmbH & Co. KG · Jun 2017
Digital Automatic Blood Pressure Monitor MD3600
K163679 · Grandway Technology (Shenzhen) Limited · Jun 2017
Matrix Data Management System
K162463 · Global Instrumentation, LLC · May 2017