# K043437: Full Automatic (Nibp) Blood Pressure Monitor, Model HL168ET

- Pathway: 510(k) (Special)
- Applicant: Health & Life Co., Ltd.
- Decided: Jan 12, 2005 after 30 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
No predicates in its family tree.
13 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K093831: Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RT (2010), 12 descendants of its own
- K131121: Full Automatic (Nibp) Blood Pressure Monitor (2013), 9 descendants of its own
- 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

## Indications for use
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel and measurements will be announced in English (optional). The intended use of this over-the counter device is for age 16 and above.

Source page: https://510kreport.com/device/K043437
Methodology: https://510kreport.com/methodology