# K030221: Mytech / Happy Life Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mytech Technology Co., Ltd.
- Decided: Jul 25, 2003 after 185 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
- K061959: Mytech / Happy Life / Maxiaids Arm Blood Pressure Monitor, HPL-301, HPL-302, HPL-310, 180310 (2006), 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 arm. The cuff circumference is limited to be 7”-15”.

Source page: https://510kreport.com/device/K030221
Methodology: https://510kreport.com/methodology
