Cleared Special

K182018 - Bluetooth blood pressure monitor

K182018 is the FDA 510(k) clearance for Bluetooth blood pressure monitor by Shenzhen Kingyield Technology Co., Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 71-day FDA review.

K182018 · Shenzhen Kingyield Technology Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
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Oct 2018
Decision
71d
Days
Class 2
Risk

K182018 is an FDA 510(k) clearance for the Bluetooth blood pressure monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Shenzhen Kingyield Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 6, 2018 after a review of 71 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 Shenzhen Kingyield Technology Co., Ltd. devices

Submission Details

510(k) Number K182018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2018
Decision Date October 06, 2018
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
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 500
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K182018.
Finapres Nova Noninvasive Hemodynamic Monitor
K173916 · Finapres Medical Systems B.V. · Nov 2018
Wrist Blood Pressure Monitor Model BP6100
K182127 · Omron Healthcare, Inc. · Nov 2018
Full Automatic(NIBP) Blood Pressure Monitor
K180240 · Health & Life Co., Ltd. · Oct 2018
Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style
K181104 · Shenzhen Combei Technology Co., Ltd. · Aug 2018
Non-invasive blood pressure measurement systems
K173024 · Joytech Healthcare Co. , Ltd. · Aug 2018
Arm Type Blood Pressure Monitor
K180155 · Avita Corporation · Aug 2018