Korotkoff sound blood pressure monitor— 510(k) K253982
Substantially EquivalentBeijing Hanvon Health Technology Co., Ltd.
FDA 510(k) clearance K253982 for Korotkoff sound blood pressure monitor, Substantially Equivalent on 2026-04-21. Applicant: Beijing Hanvon Health Technology Co., Ltd.. Device class: 2.
Summary
Beijing Hanvon Health Technology's Korotkoff sound blood pressure monitor is filed under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). The name is generic.
Class II, 21 CFR 870.1130. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
Beijing Hanvon Health Technology filed from Beijing, China. The record shows 130 calendar days from receipt to decision (December 12, 2025 to April 21, 2026).
Clearance details
- Applicant
- Beijing Hanvon Health Technology Co., Ltd.
- Product code
- Product code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beijing, CN
Recent devices under product code DXN
view all- K260670 — YUWELL® Electronic Blood Pressure Monitor
- K260470 — Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)
- K261929 — Upper Arm Blood pressure monitor (BP7155D)
- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
Adverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.