# K250231: Automatic Upper Arm Blood Pressure Monitor  (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan E-Test Technology Co., Ltd.
- Decided: Sep 3, 2025 after 219 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: 4 generations back to K123882 (2013). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193627: Automatic Upper Arm Blood Pressure Monitor, Dongguan E-Test Technology Co., Ltd. (2020) Summary page 5.

## Indications for use
Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual.

Source page: https://510kreport.com/device/K250231
Methodology: https://510kreport.com/methodology