# K160019: U80 Series Upper Arm Electronic Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Urion Technology Co., Ltd.
- Decided: Apr 22, 2016 after 108 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: 1 generation back to K001670 (2000). 1 ancestor in all.
7 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001670: Automatic Blood Pressure Monitor with Intellisense, Model Hem-757, Omron Healthcare, Inc. (2000) Summary page 6.

## Most influential descendants
- 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)) (2025), 1 descendant of its own
- K241129: Upper Arm Electronic Blood Pressure Monitor (2024), 1 descendant of its own
- K220886: Upper Arm Type  Blood Pressure Monitor (2022), 1 descendant of its own
- 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
- K243118: Arm Blood Pressure Monitor (model: BPM-A7VL) (2024), 0 descendants of its own

## Indications for use
The U80 Series Upper Arm Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-36cm.Suitable for adults who over the age of 12.

Source page: https://510kreport.com/device/K160019
Methodology: https://510kreport.com/methodology