# K113238: Full Automatic (Nibp) Blood Pressue Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Health & Life Co., Ltd.
- Decided: Mar 1, 2012 after 120 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). 16 ancestors in all.
9 later devices descend from it; 1 cites 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.
- K043217: A&D Medical UA-767PBT Digital Blood Pressure Monitor, A&D Engineering, Inc. (2005) 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
HL888HD 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 use by people over the age of 18 with arm circumference ranging from approx.9 inches to 17 inches (23 cm to 43 cm) and for home use. HL888HD features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth device after measurement.

Source page: https://510kreport.com/device/K113238
Methodology: https://510kreport.com/methodology