FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
K Number: K254048
·
Decision May 14, 2026
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
8
Review Days
148
Basic Information
- Device Name
- Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
- K Number
- K254048
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Urion Technology Co., Ltd.
- Date Received
- December 17, 2025
- Decision Date
- May 14, 2026
- Product Code
- DXN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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Other Clearances by Shenzhen Urion Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| 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 | Substantially Equivalent |
| K250046 | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) | Apr 25, 2025 | Substantially Equivalent |
| 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 | Substantially Equivalent |
| K241007 | Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) | Oct 24, 2024 | Substantially Equivalent |
| K200802 | Infrared Thermometer | Oct 7, 2020 | Substantially Equivalent |
| K160019 | U80 Series Upper Arm Electronic Blood Pressure Monitor | Apr 22, 2016 | Substantially Equivalent |
| K141683 | ELECTRONIC BLOOD PRESSURE MONITOR | Apr 3, 2015 | Substantially Equivalent |