FDA 510(k)

A&D Medical UM-212BLE Blood Pressure Monitor

K-Number: K212168 · 2022-10-06

Decision Date2022-10-06

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

A&D Medical UM-212BLE Blood Pressure Monitor is a medical device manufactured by A&D Company, Ltd.. It received FDA 510(k) clearance on 2022-10-06 under approval number K212168. 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 A&D Medical UM-212BLE Blood Pressure Monitor?

A&D Medical UM-212BLE Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2022-10-06. It is manufactured by A&D Company, Ltd.. The 510(k) number is K212168.

When was A&D Medical UM-212BLE Blood Pressure Monitor approved by the FDA?

A&D Medical UM-212BLE Blood Pressure Monitor received FDA 510(k) clearance on 2022-10-06, under approval number K212168.

What company makes A&D Medical UM-212BLE Blood Pressure Monitor?

A&D Medical UM-212BLE Blood Pressure Monitor is manufactured by A&D Company, Ltd..

What is the FDA product code for A&D Medical UM-212BLE Blood Pressure Monitor?

The FDA product code for A&D Medical UM-212BLE Blood Pressure Monitor is DXN.

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Related PubMed Literature

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) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by A&D Company, Ltd.

K151953A&D Medical TM-2657 Family of Digital Blood Pressure Monitors K170196A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor K163683A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor K173065A&D Medical Blood Pressure Monitors K173191A&D Medical Blood Pressure Monitors

Related Devices (Code: DXN)

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Official Source

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