# K240102: Blood Pressure Monitor (TMB-2287-B)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Transtek Medical Electronics Co., Ltd.
- Decided: Apr 29, 2024 after 104 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: 7 generations back to K061822 (2006). 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)
- K232713: Blood Pressure Monitor, Guangdong Transtek Medical Electronics Co., Ltd. (2023) Summary page 5.

## 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"), 22cm to 42cm (about 8¾"-16½"), 22cm to 45cm (about 8¾"-17¾") or 40cm to 52cm (about 15¾"-20½"). It is intended for adult indoor use only.

Source page: https://510kreport.com/device/K240102
Methodology: https://510kreport.com/methodology