# K190134: Full Automatic (NIBP) Blood Pressure Monitor-HL158TB

- Pathway: 510(k) (Special)
- Applicant: Health & Life Co., Ltd.
- Decided: May 20, 2019 after 112 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: 2 generations back to K093824 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160336: Full Automatic (NIBP) Blood Pressure Monitor, Health & Life Co., Ltd. (2016) Summary page 4.

## Indications for use
HL158TB 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. HL158TB 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.

Source page: https://510kreport.com/device/K190134
Methodology: https://510kreport.com/methodology