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FDA 510(k)

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

K-Number: K222979 · 2023-05-19

ApplicantMicrolife Intellectual Property GmbH
Decision Date2023-05-19
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W is a medical device manufactured by Microlife Intellectual Property GmbH. It received FDA 510(k) clearance on 2023-05-19 under approval number K222979. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W?

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W is a medical device that received FDA 510(k) clearance on 2023-05-19. It is manufactured by Microlife Intellectual Property GmbH. The 510(k) number is K222979.

When was Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W approved by the FDA?

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W received FDA 510(k) clearance on 2023-05-19, under approval number K222979.

What company makes Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W?

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W is manufactured by Microlife Intellectual Property GmbH.

What is the FDA product code for Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W?

The FDA product code for Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W is DXN.

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)

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Related Devices (Code: DXN)

K162092Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc. K161708Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. K162230Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd. K160349Electronic SphygmomanometerGuangdong Biolight Meditech Co., Ltd. K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure DeviceGuangdong Transtek Medical Electronics Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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