# K013033: Modification to: HL168W Touch Screen

- Pathway: 510(k) (Special)
- Applicant: Health & Life Co., Ltd.
- Decided: Oct 23, 2001 after 43 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/K013033
Methodology: https://510kreport.com/methodology