# K033043: Modification to HL168

- Pathway: 510(k) (Special)
- Applicant: Health & Life Co., Ltd.
- Decided: Oct 10, 2003 after 11 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
Measwes automatically human’s Systolic, Diastolic blood pressure and heart the oscillomctrk method. All values can be read out in one LCD Panel. Thc intended use of this over-the counter device is for age 16 and above,

Source page: https://510kreport.com/device/K033043
Methodology: https://510kreport.com/methodology