# K031835: HL888RA

- Pathway: 510(k) (Special)
- Applicant: Health & Life Co., Ltd.
- Decided: Jul 1, 2003 after 29 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 Sys dit, Dias dic blood pressure and heal. 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 adult patients whose arm circumference between 24-32cm (approx. 8.7” to 12.6”).

Source page: https://510kreport.com/device/K031835
Methodology: https://510kreport.com/methodology