# K030561: Mytech/Happy Life Blood Pressure Monitor, Models HPL-100 and HPL-100A

- Pathway: 510(k) (Traditional)
- Applicant: Mytech Technology Co., Ltd.
- Decided: May 9, 2003 after 77 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K041228: Mytech/Happy Life Blood Pressure Monitor, Model HPL-200 (2004), 0 descendants of its own

## Indications for use
The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.25” - 7.75”.

Source page: https://510kreport.com/device/K030561
Methodology: https://510kreport.com/methodology