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FDA 510(k)

Korotkoff sound blood pressure monitor

K-Number: K253982 · 2026-04-21

ApplicantBeijing Hanvon Health Technology Co., Ltd.
Decision Date2026-04-21
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Korotkoff sound blood pressure monitor is a medical device manufactured by Beijing Hanvon Health Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-21 under approval number K253982. 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 Korotkoff sound blood pressure monitor?

Korotkoff sound blood pressure monitor is a medical device that received FDA 510(k) clearance on 2026-04-21. It is manufactured by Beijing Hanvon Health Technology Co., Ltd.. The 510(k) number is K253982.

When was Korotkoff sound blood pressure monitor approved by the FDA?

Korotkoff sound blood pressure monitor received FDA 510(k) clearance on 2026-04-21, under approval number K253982.

What company makes Korotkoff sound blood pressure monitor?

Korotkoff sound blood pressure monitor is manufactured by Beijing Hanvon Health Technology Co., Ltd..

What is the FDA product code for Korotkoff sound blood pressure monitor?

The FDA product code for Korotkoff sound blood pressure monitor 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)

Related Devices (Code: DXN)

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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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