Index BPM
FDA 510(k) K221486 · Ya Horng Electronic Co., Ltd.
510(k) numberK221486
Submission
- Device name
- Index BPM
- Applicant
- Ya Horng Electronic Co., Ltd.
Taiwan, TW - Received
- May 23, 2022
- Decision date
- August 30, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K121025 | Ya Horng Blood Pressure Monitor, Ya Horng Blood Pressure Monitor, Bluetooth TransmissionDXN · Traditional | 08/17/2012SE |
| K090058 | Ya Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T, BP700U, BP-700B…DXN · Traditional | 04/22/2009SE |
| K081590 | Ya Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R, BP-600U…DXN · Traditional | 06/19/2008SE |
| K072860 | Ya Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J; Digital Wrist Blood…DXN · Traditional | 02/25/2008SE |
| K051862 | PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U, BP-410R; Automatic…DXN · Traditional | 08/23/2005SE |
| K051863 | Amluck, Ya HorngDXN · Traditional | 08/19/2005SE |
| K051539 | Tricot Blood Pressure CuffDXQ · Traditional | 08/05/2005SE |
| K042581 | Amluck, Ya HorngDXN · Traditional | 10/13/2004SE |
| K040528 | Amluck Ya Horng PC Compatible Wrist Blood Pressure Monitor, Model AK-4000TDXN · Traditional | 04/15/2004SE |
Questions and answers
When was Index BPM cleared by the FDA?
Index BPM (K221486) received a 510(k) decision of Substantially Equivalent on August 30, 2022, 99 days after the submission was received.
What is the product code of K221486?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.