Cleared Special

K191593 - Digital Automatic Blood Pressure Monitor MD36 Series

K191593 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 Special 510(k) pathway after a 38-day FDA review.

K191593 · Grandway Technology (Shenzhen) Limited · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
38d
Days
Class 2
Risk

K191593 is an FDA 510(k) clearance for the Digital Automatic Blood Pressure Monitor MD36 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 July 22, 2019 after a review of 38 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.

FDA 510(k) Submission Details - K191593

510(k) Number K191593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2019
Decision Date July 22, 2019
Days to Decision 38 days
Submission Type Special
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
87d faster than avg
Panel avg: 125d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

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 1207
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K191593.
Non-invasive Hemodynamic Blood Pressure Monitor
K190893 · Vita-Course Technologies Co., Ltd. · Aug 2019
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Non-invasive blood pressure measurement systems
K190886 · Joytech Healthcare Co. , Ltd. · Jul 2019
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K190818 · Microlife Intellectual Property GmbH · Jul 2019
Arm-type Electronic Blood Pressure Monitor
K183058 · Shenzhen Bsx Technology Electronics Co., Ltd. · Jul 2019
Oscillometric Blood Pressure Monitor
K190927 · Rudolf Riester GmbH · Jun 2019
K191593 · Digital Automatic Blood Pressure Monitor MD36 Series
Download PDF FDA Summary Grandway Technology (…