System, Measurement, Blood-Pressure, Non-Invasive
The U80 Series is an electronic monitor for measuring systolic and diastolic blood pressure and pulse rate. Its listed method is non-invasive oscillometry, using an inflatable cuff around…
The U80 Series is an electronic monitor for measuring systolic and diastolic blood pressure and pulse rate. Its listed method is non-invasive oscillometry, using an inflatable cuff around the upper arm.
The filing lists U80A among the covered U80 Series models, matching the model example for this listing. It says the monitor is intended for use at home or in medical facilities for people over age 12.
Measurement and Use
The filing describes an automatic, battery-driven monitor that completes inflation, deflation and measurement. Its stated cuff circumference range is 22 to 36 cm.
Who Else Makes It
Concentrated in Guangdong (67), Jiangsu (11), Zhejiang (6). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Taizhou Rich Medical Products Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 20 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Honsun (Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 9 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| Guangzhou Daxin Health Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Dongguan Polygreen Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shenzhen Brav Electronic Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 3 |
Showing 12 of 98. All 98 manufacturers in China registered for System, Measurement, Blood-Pressure, Non-Invasive
Record
| Listed by | Shenzhen Urion Technology Co., Ltd., China |
|---|---|
| FDA product code | DXN |
| Device type | System, Measurement, Blood-Pressure, Non-Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1130 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K160019 |
| Record published | 2023-06-28 |
| Record revised | 2025-05-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Carton of 20, carton of 24, carton of 30, carton of 8, carton of 40, carton of 36 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 81V | In distribution | |
| U80B | In distribution | |
| U81CH | In distribution | |
| U83Z | In distribution | |
| U81Z | In distribution | |
| U85H | In distribution | |
| U82E | In distribution | |
| U81V | In distribution | |
| U82V | In distribution | |
| U80V | In distribution | |
| U90B Pro | In distribution | |
| U16P | In distribution | |
| U82Y | In distribution | |
| U81X | In distribution | |
| U90B | In distribution | |
| U82Z | In distribution | |
| U81E | In distribution | |
| U80Y | In distribution | |
| U87E | In distribution | |
| U80AH | In distribution | |
| U80Y | In distribution | |
| U81NH | In distribution | |
| U16H | In distribution | |
| U80AH | In distribution | |
| U82NH | In distribution | |
| U80B | In distribution | |
| U80A | In distribution | |
| U90B Pro | In distribution | |
| U81U | In distribution | |
| U80W | In distribution | |
| U82V | In distribution | |
| U82V | In distribution | |
| U80EH | In distribution | |
| U80BH | In distribution | |
| U85W | In distribution | |
| U60A | In distribution | |
| U86E | In distribution | |
| U80B | In distribution | |
| U80N | In distribution | |
| U80A | In distribution | |
| U90B Pro | In distribution | |
| U80A | In distribution | |
| U80AH | In distribution | |
| U82V | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Baum | W.A. Baum Co., Inc. | 116 |
| Alphamed | Shenzhen Urion Technology Co., Ltd. | 68 |
| Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | 59 |
| Arm Type Automatic Blood Pressure Monitor | Shenzhen Jiacom Technology Co., Ltd. | 58 |
| A&D Medical | A&D Company, Ltd. | 56 |
| Diagnostix™ | American Diagnostic Corp. | 54 |
| Lutech | Lutech Industries | 51 |
| Veridian | Veridian Healthcare | 50 |
| Hopkins Medical Products® | Hopkins Uniform Company | 49 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 49 |
| Merit Medical® | Argon Critical Care Systems Singapore PTE. Ltd. | 48 |
| SunTech | Suntech Medical, Inc. | 46 |
Showing 12 of 1,292. All products under System, Measurement, Blood-Pressure, Non-Invasive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254048 | 2026-05-14 |
| K260273 | 2026-03-26 |
| K243115 | 2025-02-21 |
| K241007 | 2024-10-24 |
| K160019 | 2016-04-22 |
| K141683 | 2015-04-03 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.