# K240832: Blood Pressure Monitor (BBZ32-AA01)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Transtek Medical Electronics Co., Ltd.
- Decided: Jun 7, 2024 after 73 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: 3 generations back to K052153 (2005). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133379: HEM-7311, Omron Healthcare, Inc. (2014) Summary page 5.

## Most influential descendants
- K253124: Upper arm electronic blood pressure monitor (XB-01) (2026), 0 descendants of its own

## Indications for use
This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 22cm to 32cm (about 8¾"-12½") or 22cm to 42cm (about 8¾"-16½"). It is intended for adult indoor use only.

Source page: https://510kreport.com/device/K240832
Methodology: https://510kreport.com/methodology