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FDA 510(k)

InBody Blood pressure monitor, Model BPBIO480KV

K-Number: K221764 · 2022-10-07

ApplicantInbody Co., Ltd.
Decision Date2022-10-07
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

InBody Blood pressure monitor, Model BPBIO480KV is a medical device manufactured by Inbody Co., Ltd.. It received FDA 510(k) clearance on 2022-10-07 under approval number K221764. 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 InBody Blood pressure monitor, Model BPBIO480KV?

InBody Blood pressure monitor, Model BPBIO480KV is a medical device that received FDA 510(k) clearance on 2022-10-07. It is manufactured by Inbody Co., Ltd.. The 510(k) number is K221764.

When was InBody Blood pressure monitor, Model BPBIO480KV approved by the FDA?

InBody Blood pressure monitor, Model BPBIO480KV received FDA 510(k) clearance on 2022-10-07, under approval number K221764.

What company makes InBody Blood pressure monitor, Model BPBIO480KV?

InBody Blood pressure monitor, Model BPBIO480KV is manufactured by Inbody Co., Ltd..

What is the FDA product code for InBody Blood pressure monitor, Model BPBIO480KV?

The FDA product code for InBody Blood pressure monitor, Model BPBIO480KV is DXN.

Related Clinical Trials

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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)

Other Devices by Inbody Co., Ltd.

K200442InBody K200560InBody K231174BPBIO750

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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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