# K160557: Full Automatic (NIBP) Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Health & Life Co., Ltd.
- Decided: Jul 6, 2016 after 128 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: 3 generations back to K042505 (2005). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093824: Full Automatic (Nibp) Blood Pressure Monitor, Model HL158BT, Health & Life Co., Ltd. (2010) Summary page 4.
- K142917: BP652N (Hem-6300-Z), Omron Healthcare, Inc. (2014) Summary page 4.

## Most influential descendants
- K162338: Full Automatic (NIBP) Blood Pressure Monitor (2016), 2 descendants of its own
- K201914: HRVWatch-Mini Wrist Monitor (2021), 0 descendants of its own
- K190133: Full Automatic (NIBP) Blood Pressure Monitor-HL158UB (2019), 0 descendants of its own

## Indications for use
HL158VA 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 wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx. 135 mm to 195 mm) and for home use. HLI58VA 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. Besides, the device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users could simply synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek® application software with the paired Bluetooth-enabled device.

Source page: https://510kreport.com/device/K160557
Methodology: https://510kreport.com/methodology