# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Joytech Healthcare Co., Ltd.
- Decided: Feb 13, 2026 after 171 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 6.

## Indications for use
Arm-type Fully Automatic Digital Blood Pressure Monitors(Model: DBP-62F4L, DBP-62F4B, DBP-61F4, DBP-61F4L, DBP-61D2L, DBP-63D2L, DBP-61D9L, DBP-63D9L) are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 42cm. Arm-Type Fully Automatic Digital Blood Pressure Monitor( Model: DBP-61D2L-P, DBP-63D2L-P, DBP-61D9L-P, DBP-63D9L-P, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 42cm. The device is also indicated in pregnant women with normotension, gestational hypertension, or preeclampsia with circumference ranging from 22cm to 42cm.

Source page: https://510kreport.com/device/K252685
Methodology: https://510kreport.com/methodology