# K253982: Korotkoff sound blood pressure monitor

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Hanvon Health Technology Co., Ltd.
- Decided: Apr 21, 2026 after 130 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K903134 (1991). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251120: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B), Microlife Corporation (2025) Summary page 5.

## Indications for use
The device is a digital monitor intended for use in measuring the systolic pressure and diastolic pressure, as well as the pulse rate of adults and adolescents via a non-invasive auscultatory method in medical facilities or at home, with an inflatable cuff wrapped around the upper arm for arm circumferences ranging from 22 to 42 cm. The measurement ranges of the device are systolic pressure 40 ~ 280 mmHg (supported by automatic mode for 40 to 210 mmHg and manual mode for 210 to 280 mmHg), diastolic pressure 20 ~ 220 mmHg, and pulse rate 40 ~ 240 beats/min. The device can detect Irregular Heart Beat (IHB), Atrial Fibrillation, Tachycardia, and evaluate Blood Pressure Variability (BPV) and Time in Target Range (TTR) according to the measured blood pressure values.

Source page: https://510kreport.com/device/K253982
Methodology: https://510kreport.com/methodology