# K131121: Full Automatic (Nibp) Blood Pressure Monitor

- Pathway: 510(k) (Special)
- Applicant: Health & Life Co., Ltd.
- Decided: May 29, 2013 after 37 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: 7 generations back to K850316 (1985). 14 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093831: Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RT, Health & Life Co., Ltd. (2010) Summary page 1.

## Most influential descendants
- 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
- K190507: Full Automatic (NIBP) Blood Pressure Monitor (2019), 2 descendants of its own
- K180240: Full Automatic (NIBP) Blood Pressure Monitor (2018), 1 descendant 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/K131121
Methodology: https://510kreport.com/methodology