Omron Model BP7900 Blood Pressure Monitor + EKG
FDA 510(k) K202228 · Omron Healthcare, Inc.
510(k) numberK202228
Submission
- Device name
- Omron Model BP7900 Blood Pressure Monitor + EKG
- Applicant
- Omron Healthcare, Inc.
Lake Forest, IL, US - Received
- August 7, 2020
- Decision date
- April 1, 2021
- 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 |
|---|---|---|
| K261929 | Upper Arm Blood pressure monitor (BP7155D)DXN · Special | 09/10/2026SE |
| K183215 | Focus TENS Therapy, Model PM710-M/-LNUH · Traditional | 09/07/2019SE |
| K190693 | HEM-6410T-ZL Wrist Blood Pressure MonitorDXN · Special | 04/17/2019SE |
| K182579 | Omron Model BP7900 Blood Pressure Monitor + EKGDXN · Traditional | 03/14/2019SE |
| K182120 | Maxpower ReliefNUH · Traditional | 01/10/2019SE |
| K182481 | HEM-6410T-ZM Wrist Blood Pressure MonitorDXN · Traditional | 11/09/2018SE |
| K181992 | Heat Pain ProNUH · Traditional | 11/09/2018SE |
| K182166 | Wrist Blood Pressure Monitor Model BP4350DXN · Traditional | 11/08/2018SE |
| K182127 | Wrist Blood Pressure Monitor Model BP6100DXN · Traditional | 11/02/2018SE |
| K172079 | AvailNUH · Traditional | 10/19/2017SE |
Questions and answers
When was Omron Model BP7900 Blood Pressure Monitor + EKG cleared by the FDA?
Omron Model BP7900 Blood Pressure Monitor + EKG (K202228) received a 510(k) decision of Substantially Equivalent on April 1, 2021, 237 days after the submission was received.
What is the product code of K202228?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.