# K232621: Blood pressure monitor

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Transtek Medical Electronics Co., Ltd.
- Decided: Nov 22, 2023 after 85 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: 10 generations back to K903134 (1991). 30 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202891: Blood Pressure Monitor, Guangdong Transtek Medical Electronics Co., Ltd. (2021) Summary page 4.
- K181832: Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device, Guangdong Transtek Medical Electronics Co., Ltd. (2019) Summary page 4.
- K222979: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W, Microlife Intellectual Property GmbH (2023) Summary page 4.

## Most influential descendants
- K253425: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P) (2026), 0 descendants of its own
- K252685: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) (2026), 0 descendants of its own
- K241351: Blood Pressure Monitor (TMB-2092-G) (2024), 0 descendants of its own

## 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) or 22 to 45cm (8.6 to 17.7 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. It is intended indoor use only.

Source page: https://510kreport.com/device/K232621
Methodology: https://510kreport.com/methodology