Class Class II

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W (K222979)

K222979 2023-05-19 Traditional
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Description

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W by Microlife Intellectual Property GmbH, an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK222979
Clearance Date2023-05-19
Clearance TypeTraditional
Product CodeDXN
Regulation Number870.1130

Categories

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Predicate lineage for K222979

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. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W (K222979) cites 2 predicate devices and is itself cited by 2 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K183469Microlife Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH2019
K153077Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH2016

Later devices that cite this one as their predicate

Devices that cite K222979
K numberDeviceApplicantYear
K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing...2024
K232621Blood pressure monitorGuangdong Transtek Medical Electron...2023

Trace the full predicate network for K222979

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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