Class Class II

Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 (K222926)

K222926 2023-05-05 Traditional
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Description

Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 by Shenzhen Yuezhongxing Technology Co., Ltd., an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK222926
Clearance Date2023-05-05
Clearance TypeTraditional
Product CodeDXN
Regulation Number870.1130

Categories

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Predicate lineage for K222926

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 (K222926) cites 1 predicate device and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K193627Automatic Upper Arm Blood Pressure MonitorDongguan E-Test Technology Co., Ltd.2020

Later devices that cite this one as their predicate

Devices that cite K222926
K numberDeviceApplicantYear
K241590Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05,...Guangdong Xinyu Electronic and Tech...2025

Trace the full predicate network for K222926

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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