# K251307: Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Hingmed Medical Instrument Co., Ltd.
- Decided: Jan 12, 2026 after 259 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: 8 generations back to K982481 (1998). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231984: Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP), Shenzhen Hingmed Medical Instrument Co., Ltd. (2024) Summary page 5.

## Indications for use
This device is a digital monitor intended for use in measuring blood pressure(SYS and DIA) and pulse rate ,and the physician reference the result to diagnose. Environments of use: Hospital and other medical establishment(contraindicate the home as an environment of use). Patient population: Adult (exclude pregnant women ).

Source page: https://510kreport.com/device/K251307
Methodology: https://510kreport.com/methodology