# K260273: Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Urion Technology Co., Ltd.
- Decided: Mar 26, 2026 after 56 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: 3 generations back to K001670 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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)), Shenzhen Urion Technology Co., Ltd. (2025) Summary page 6.

## Indications for use
This automatic blood pressure s intended tomeasure systolic pressure, diastolic pressure and pulse rate through upper arm.Are expected to use in the home orin the hospital, intended for people over 12 years old. The Subject device is not intended to be diagnostic device.

Source page: https://510kreport.com/device/K260273
Methodology: https://510kreport.com/methodology