# Shenzhen Urion Technology Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 8 (2015–2026): 8 510(k) clearances
- Product codes: DXN (6), FLL (1), IRP (1)
- 510(k) review time since 2016: median 144 days, against 144 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 8 (2 its own); citations of its devices by later devices: 5 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kodon (Tianjin)Electronic&Electrical Apparatus Co.,: 1 (https://510kreport.com/company/kodon-tianjin-electronic-electrical-apparatus)
- Omron Healthcare, Inc.: 1 (https://510kreport.com/company/omron-healthcare)
- Zhuhai Linte Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/zhuhai-linte-medical-instrument)
- Shenzhen AOJ Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-aoj-medical-technology)
- Xiamen Emoka Health Science & Technology Co., Ltd.: 1 (https://510kreport.com/company/xiamen-emoka-health-science-technology)
- Shenzhen Finicare Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-finicare)

## Firms that cite its devices most
- Shenzhen Jamr Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-jamr-technology)
- Shenzhen Goodlymed Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-goodlymed-technology)
- Alicn Medical Shenzhen, Inc.: 1 (https://510kreport.com/company/alicn-medical-shenzhen)

## Its most-cited devices
- K160019: U80 Series Upper Arm Electronic Blood Pressure Monitor (2016), cited by 4
- 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), cited by 1

## Recent decisions
- K254048: Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) (May 14, 2026)
- K260273: Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) (Mar 26, 2026)
- K250046: Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) (Apr 25, 2025)
- 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)) (Feb 21, 2025)
- K241007: Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) (Oct 24, 2024)
- K200802: Infrared Thermometer (Oct 7, 2020)
- K160019: U80 Series Upper Arm Electronic Blood Pressure Monitor (Apr 22, 2016)
- K141683: Electronic Blood Pressure Monitor (Apr 3, 2015)

Source page: https://510kreport.com/company/shenzhen-urion-technology