Cleared Special

K182018 - Bluetooth blood pressure monitor (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K182018 · Shenzhen Kingyield Technology Co., Ltd. · Cardiovascular device
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.

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
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 140d · 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 45
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K182018.
Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)
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YUWELL® Electronic Blood Pressure Monitor (YE630CR)
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YUWELL® Electronic Blood Pressure Monitor (YE650AR)
K253228 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Feb 2026
Wrist Blood Pressure Monitor (BPM-W1VL)
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Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)
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Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
K251581 · Shenzhen Hingmed Medical Instrument Co., Ltd. · Feb 2026