# K153214: Full Automatic (NIBP) Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Health & Life Co., Ltd.
- Decided: Jan 7, 2016 after 63 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: 9 generations back to K850316 (1985). 21 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142968: Full Automatic (NIBP) Blood Pressure Monitor, Health & Life Co., Ltd. (2014) Summary page 4.

## Most influential descendants
- K180240: Full Automatic (NIBP) Blood Pressure Monitor (2018), 1 descendant of its own
- K211127: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM (2021), 0 descendants of its own
- K161156: Full Automatic (NIBP) Blood Pressure Monitor (2016), 0 descendants of its own

## Indications for use
HL858DI 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 one LCD panel. Measurement position is at human being’s upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use. HL858DI detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.

Source page: https://510kreport.com/device/K153214
Methodology: https://510kreport.com/methodology