# K093831: Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RT

- Pathway: 510(k) (Special)
- Applicant: Health & Life Co., Ltd.
- Decided: Mar 25, 2010 after 101 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: 6 generations back to K850316 (1985). 13 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092161: Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BF, Health & Life Co., Ltd. (2009) Summary page 1.
- K043437: Full Automatic (Nibp) Blood Pressure Monitor, Model HL168ET, Health & Life Co., Ltd. (2005) Summary page 1.

## Most influential descendants
- K131121: Full Automatic (Nibp) Blood Pressure Monitor (2013), 9 descendants of its own
- K142968: Full Automatic (NIBP) Blood Pressure Monitor (2014), 8 descendants of its own
- K160145: Full Automatic (NIBP) Blood Pressure Monitor (2016), 3 descendants of its own
- K153214: Full Automatic (NIBP) Blood Pressure Monitor (2016), 3 descendants of its own
- K130563: Full Automatic (Nibp) Blood Pressure Monitor (2013), 3 descendants of its own

## Indications for use
This device automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. 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. When the device detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring readings. And this device can let the memory data be transferred to the connected personal computer (PC) via USB cable.

Source page: https://510kreport.com/device/K093831
Methodology: https://510kreport.com/methodology