Oscillometric Blood Pressure Monitor
FDA 510(k) K190927 · Rudolf Riester GmbH
510(k) numberK190927
Submission
- Device name
- Oscillometric Blood Pressure Monitor
- Applicant
- Rudolf Riester GmbH
Jungingen, DE - Received
- April 9, 2019
- Decision date
- June 24, 2019
- 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 |
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| K170538 | RVS-100 Vital Signs MonitorMWI · Traditional | 10/17/2017SE |
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| K002955 | Empire N Blood Pressure ManometersDXQ · Traditional | 12/21/2000SE |
| K002954 | Ri-San/Ri-Sana Blood Pressure ManometersDXQ · Traditional | 12/21/2000SE |
| K972379 | Precisa NDXQ · Traditional | 09/24/1997SE |
| K972378 | Sanaphon NDXQ · Traditional | 09/24/1997SE |
| K972377 | Ri-MegaDXQ · Traditional | 09/24/1997SE |
| K972301 | Big Ben Square, Big Ben RoundDXQ · Traditional | 09/17/1997SE |
| K964338 | Ri-Tiniscope-Slit/Ri-Tiniscope Spot/Ri-Vision-Slit/Ri-Vision-SpotHKM · Traditional | 01/09/1997SE |
| K950914 | Ri-Former Wall Model 2,5 V/220 V or 110 V 3,5 V/220 V or 110 V, Ri-Former Anaesthetic…HLJ · Traditional | 07/24/1995SE |
Questions and answers
When was Oscillometric Blood Pressure Monitor cleared by the FDA?
Oscillometric Blood Pressure Monitor (K190927) received a 510(k) decision of Substantially Equivalent on June 24, 2019, 76 days after the submission was received.
What is the product code of K190927?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.