Cleared Special

K163113 - Digital Automatic Wrist Blood Pressure ...

K163113 is the FDA 510(k) clearance for Digital Automatic Wrist Blood Pressure ... by Grandway Technology (Shenzhen) Limited. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 73-day FDA review.

K163113 · Grandway Technology (Shenzhen) Limited · Cardiovascular device
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Jan 2017
Decision
73d
Days
Class 2
Risk

K163113 is an FDA 510(k) clearance for the Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series. 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 January 19, 2017 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Grandway Technology (Shenzhen) Limited devices

Submission Details

510(k) Number K163113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2016
Decision Date January 19, 2017
Days to Decision 73 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 501
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