# K180240: Full Automatic (NIBP) Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Health & Life Co., Ltd.
- Decided: Oct 17, 2018 after 261 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: 10 generations back to K850316 (1985). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153214: Full Automatic (NIBP) Blood Pressure Monitor, Health & Life Co., Ltd. (2016) Summary page 4.
- K130563: Full Automatic (Nibp) Blood Pressure Monitor, Health & Life Co., Ltd. (2013) Summary page 4.

## Most influential descendants
- K211127: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM (2021), 0 descendants of its own

## Indications for use
HL858DK automatically measures human’s systolic, diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in the LCD panel. Measurement position is at human being’s upper arm. The intended user of this over-the-counter device is adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) for home use. HL858DK features BP Category Indicator that will show the information with the readings on the screen for the user tracking their blood pressure level. HL858DK is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with deviation, the device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected.

Source page: https://510kreport.com/device/K180240
Methodology: https://510kreport.com/methodology