Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor
FDA 510(k) K181154 · Shenzhen Med-Link Electronics Tech Co., Ltd.
510(k) numberK181154
Submission
- Device name
- Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor
- Applicant
- Shenzhen Med-Link Electronics Tech Co., Ltd.
Shenzhen, CN - Received
- May 1, 2018
- Decision date
- August 2, 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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| K220447 | Med-link Disposable ECG Cable and LeadwiresDSA · Traditional | 06/28/2022SE |
| K212752 | Med-link Pulse OximeterDQA · Traditional | 05/20/2022SE |
| K210441 | Incontinence ProbeKPI · Traditional | 09/17/2021SE |
| K202743 | Med-Link Temp-pulse OximeterDQA · Traditional | 03/01/2021SE |
| K193338 | Med-link Reusable Temperature Probes, Med-link Disposable Temperature ProbesFLL · Traditional | 08/25/2020SE |
| K182667 | Med-link Temperature ProbesFLL · Traditional | 06/18/2019SE |
| K173869 | Med-link Reusable Blood Pressure CuffDXQ · Traditional | 08/02/2018SE |
| K160530 | Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure CuffDXQ · Traditional | 11/28/2016SE |
Questions and answers
When was Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor cleared by the FDA?
Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor (K181154) received a 510(k) decision of Substantially Equivalent on August 2, 2019, 458 days after the submission was received.
What is the product code of K181154?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.