# K241351: Blood Pressure Monitor (TMB-2092-G)

- Pathway: 510(k) (Special)
- Applicant: Guangdong Transtek Medical Electronics Co., Ltd.
- Decided: Aug 21, 2024 after 100 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: 11 generations back to K903134 (1991). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232621: Blood pressure monitor, Guangdong Transtek Medical Electronics Co., Ltd. (2023) Summary page 5.

## Indications for use
This Blood Pressure Monitor is intended for use in measuring blood pressure and pulse rate in patients with arm circumferences from 16 to 36 cm (6.3 to 14.1 inch), 22 to 42cm (8.6 to 16.5 inch), 22 to 45cm (8.6 to 17.7 inch) or 40 to 52cm (15.7 to 20.5 inch). Cuff model AC1636-01, arm circumference range is 16~36cm (6.3 to 14.1 inch), which is intended for children older than 3 years old or adults without conditions of diabetes, pregnancy, or pre-eclampsia. Cuff model AC2245-021, arm circumference range is 22~45cm (8.6 to 17.7 inch), which is intended for adult population or those who with conditions of diabetes, pregnancy, or pre-eclampsia. Cuff model AC2242-41 and cuff model AC4052-04, arm circumference range are 22~42cm (8.6 to 16.5 inch) and 40~52cm (15.7 to 20.5 inch) respectively, which are intended for adults without conditions of diabetes, pregnancy, or pre-eclampsia. It is intended indoor use only.

Source page: https://510kreport.com/device/K241351
Methodology: https://510kreport.com/methodology