Full Automatic(NIBP) Blood Pressure Monitor
FDA 510(k) K180240 · Health & Life Co., Ltd.
510(k) numberK180240
Submission
- Device name
- Full Automatic(NIBP) Blood Pressure Monitor
- Applicant
- Health & Life Co., Ltd.
Zhonghe District, New Taipei City, TW - Received
- January 29, 2018
- Decision date
- October 17, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K211744 | Non-Contact Infrared Thermometer, model HL710HFLL · Traditional | 11/24/2021SE |
| K211127 | Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DMDXN · Traditional | 09/08/2021SE |
| K200521 | Full Automatic(NIBP) Blood Pressure MonitorDXN · Traditional | 06/12/2020SE |
| K190507 | Full Automatic (NIBP) Blood Pressure MonitorDXN · Traditional | 09/16/2019SE |
| K190133 | Full Automatic (NIBP) Blood Pressure Monitor-HL158UBDXN · Special | 06/13/2019SE |
| K190134 | Full Automatic (NIBP) Blood Pressure Monitor-HL158TBDXN · Special | 05/20/2019SE |
| K162338 | Full Automatic (NIBP) Blood Pressure MonitorDXN · Special | 09/21/2016SE |
| K160557 | Full Automatic (NIBP) Blood Pressure MonitorDXN · Traditional | 07/06/2016SE |
| K161156 | Full Automatic (NIBP) Blood Pressure MonitorDXN · Traditional | 06/14/2016SE |
| K160336 | Full Automatic (NIBP) Blood Pressure MonitorDXN · Traditional | 03/29/2016SE |
Questions and answers
When was Full Automatic(NIBP) Blood Pressure Monitor cleared by the FDA?
Full Automatic(NIBP) Blood Pressure Monitor (K180240) received a 510(k) decision of Substantially Equivalent on October 17, 2018, 261 days after the submission was received.
What is the product code of K180240?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.