# K030499: HL888HM

- Pathway: 510(k) (Special)
- Applicant: Health & Life Co., Ltd.
- Decided: Apr 17, 2003 after 57 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 adult patients whose arm circumference between 24-32cm (approx. 8.7‘’ to 12.6” ) .

Source page: https://510kreport.com/device/K030499
Methodology: https://510kreport.com/methodology