# K243661: Electronic Blood Pressure Monitor

- Pathway: 510(k) (Special)
- Applicant: Hetaida Technology Co., Ltd.
- Decided: Feb 7, 2025 after 72 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
Longest line of descent: 6 generations back to K052153 (2005). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223170: Electronic Blood Pressure Monitor, model: HTD6602US, Hetaida Technology Co., Ltd. (2023) Summary page 5.

## Indications for use
This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia).

Source page: https://510kreport.com/device/K243661
Methodology: https://510kreport.com/methodology