Cleared Traditional

K253982 - Korotkoff sound blood pressure monitor

K253982 is an FDA 510(k) clearance for Korotkoff sound blood pressure monitor, manufactured by Beijing Hanvon Health Technology Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K253982 · Beijing Hanvon Health Technology Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
130d
Days
Class 2
Risk

K253982 is an FDA 510(k) clearance for the Korotkoff sound blood pressure monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Beijing Hanvon Health Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on April 21, 2026 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Beijing Hanvon Health Technology Co., Ltd. devices

FDA 510(k) Submission Details - K253982

510(k) Number K253982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2025
Decision Date April 21, 2026
Days to Decision 130 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 125d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 840
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