# K243115: Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y  U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Urion Technology Co., Ltd.
- Decided: Feb 21, 2025 after 144 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: 2 generations back to K001670 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160019: U80 Series Upper Arm Electronic Blood Pressure Monitor, Shenzhen Urion Technology Co., Ltd. (2016) Summary page 6.

## Most influential descendants
- K260273: Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) (2026), 0 descendants of its own

## Indications for use
intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual who over the age of 12 in medical facilities or at home by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm). The Subject device is not intended to be diagnostic device.

Source page: https://510kreport.com/device/K243115
Methodology: https://510kreport.com/methodology