# K130563: Full Automatic (Nibp) Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Health & Life Co., Ltd.
- Decided: Jun 18, 2013 after 106 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). 18 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 22 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.
- K042967: A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512, A&D Engineering, Inc. (2004) Summary page 1.

## 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
- K150311: Full Automatic (NIBP)Blood Pressure Monitor (2015), 0 descendants of its own

## Indications for use
HL858GA uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being’s arm. All values can be read out in one LCD panel. The device is designed and recommended 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. 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. Besides, Risk Category Indicator (Six Levels) feature will judge blood pressure results into six levels based on WHO (World Health Organization) classification with corresponding bar segment on the edge of screen.

Source page: https://510kreport.com/device/K130563
Methodology: https://510kreport.com/methodology