Automatic Digital Blood Pressure Monitor
FDA 510(k) K132627 · Honsun (Nantong) Co., Ltd.
510(k) numberK132627
Submission
- Device name
- Automatic Digital Blood Pressure Monitor
- Applicant
- Honsun (Nantong) Co., Ltd.
Nantong, Jiangsu, CN - Received
- August 22, 2013
- Decision date
- October 23, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DXN – System, Measurement, Blood-Pressure, Non-Invasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1130
- Specialty
- Cardiovascular
Other 510(k)s with product code DXN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261929 | Upper Arm Blood pressure monitor (BP7155D)DXN · Special | OMRON Healthcare, Inc. | 09/10/2026SE |
| K254000 | Happy Health Blood Pressure MonitorDXN · Traditional | Happy Health, Inc. | 09/03/2026SE |
| K262658 | Automatic Digital Blood Pressure monitor (LD-526)DXN · Special | Honsun (Nantong) Co., Ltd. | 08/31/2026SE |
| K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…DXN · Traditional | JOYTECH Healthcare Co., Ltd. | 08/26/2026SE |
| K261061 | BP Go (BPP-855)DXN · Traditional | Wellvii, Inc. | 08/13/2026SE |
| K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor…DXN · Traditional | Joytech Healthcare Co. , Ltd. | 08/13/2026SE |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)DXN · Traditional | Guangzhou Daxin Health Technology Co., Ltd. | 07/23/2026SE |
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)DXN · Traditional | Microlife Corporation | 07/23/2026SE |
| K253126 | Wrist Blood Pressure Monitor (XW-05)DXN · Traditional | Shenzhen Ziqing Medical Equipment Co., Ltd. | 06/18/2026SE |
| K260693 | VicorderCS (VCS-SYS-1100)DXN · Traditional | 80 Beats Medical GmbH | 06/16/2026SE |
More from 80 Beats Medical GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K262658 | Automatic Digital Blood Pressure monitor (LD-526)DXN · Special | 08/31/2026SE |
| K252399 | Portable Oxygen ConcentratorCAW · Traditional | 06/17/2026SE |
| K260260 | Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521…DXN · Special | 04/28/2026SE |
| K251795 | Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)DXN · Special | 10/09/2025SE |
| K211629 | Infrared forehead thermometer LD-FT-100BFLL · Traditional | 12/08/2021SE |
| K192500 | Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometerDXQ · Traditional | 04/06/2020SE |
| K170866 | Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579DXN · Special | 02/21/2018SE |
| K170466 | Automatic Blood Pressure Monitor Model LD-518 & LD-537DXN · Traditional | 10/27/2017SE |
| K170454 | Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533UDXN · Traditional | 10/25/2017SE |
| K130925 | Automatic Blood Pressure MonitorDXN · Traditional | 09/12/2013SE |
Questions and answers
When was Automatic Digital Blood Pressure Monitor cleared by the FDA?
Automatic Digital Blood Pressure Monitor (K132627) received a 510(k) decision of Substantially Equivalent on October 23, 2013, 62 days after the submission was received.
What is the product code of K132627?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.