Class Class II

Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) (K241634)

K241634 2025-02-11 Traditional
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Description

Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) by Guangdong Xinyu Electronic and Technology Co., Ltd., an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241634
Clearance Date2025-02-11
Clearance TypeTraditional
Product CodeDXN
Regulation Number870.1130

Categories

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Predicate lineage for K241634

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. Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) (K241634) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K231310Electronic Blood Pressure MonitorShenzhen Jumper Medical Equipment C...2023

Trace the full predicate network for K241634

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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