# K261394: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)

- Pathway: 510(k) (Traditional)
- Applicant: JOYTECH Healthcare Co., Ltd.
- Decided: Aug 26, 2026 after 119 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: 8 generations back to K061822 (2006). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250548: Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186), Joytech Healthcare Co., Ltd. (2025) Summary page 6.

## Indications for use
The Arm-type Fully Automatic Digital Blood Pressure Monitors 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 and 40cm to 56cm.

Source page: https://510kreport.com/device/K261394
Methodology: https://510kreport.com/methodology