# K020766: HL168F

- Pathway: 510(k) (Special)
- Applicant: Health & Life Co., Ltd.
- Decided: Apr 5, 2002 after 28 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## 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. The intended for use of this over-the-counter device is for age 16 and above.

Source page: https://510kreport.com/device/K020766
Methodology: https://510kreport.com/methodology