Wireless Blood Pressure Wrist Monitor
510(k) K121470
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK121470 | Date14 Jun 2012 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- Fully Automatic Wireless Blood Pressure Wrist Monitor
- 510(k) Number
- FDA Product Code
- DXN
- FDA applicant
- Andon Health Co, Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is a fully automatic wireless blood pressure monitor designed for non-invasive measurement of blood pressure at the wrist. Classified as a cardiovascular diagnostic device, it utilises oscillometric technology to detect arterial pulsations and calculate systolic, diastolic, and mean arterial pressure readings without manual inflation.
The monitor is intended for home or clinical use and is supplied as a single-use or reusable device, depending on the model variant. It operates wirelessly, transmitting data to compatible companion devices or smartphones for storage and review. Authorised under FDA 510(k) clearance, MDD, and MDR compliance, it adheres to regulatory standards for accuracy and safety in blood pressure monitoring. No MRI safety classification or specific sterility requirements are noted in the specifications.
Other devices from Andon Health Co., Ltd.
Questions
AI-generated answers, 18 Sep 2026
What types of blood pressure readings does this device measure, and how does it determine them?
This device measures systolic, diastolic, and mean arterial pressure using oscillometric technology, which detects arterial pulsations at the wrist without requiring manual cuff inflation. It automates the process for convenience, making it suitable for both home and clinical use.
Is this device designed for single-use or reusable applications, and how should it be handled?
The device is available in single-use or reusable variants, depending on the specific model. The data does not specify sterilization requirements, so reusable units should follow manufacturer guidelines for cleaning and maintenance to ensure accuracy and hygiene. Single-use units should be discarded after one use.
How does this device transmit its readings, and what devices can it connect to?
This is a fully automatic wireless blood pressure monitor, meaning it transmits data wirelessly to compatible companion devices or smartphones for storage and review. This feature allows users to track trends over time without manual data entry.
What regulatory pathways has this device followed, and what does that mean for its use?
The device has been authorized under FDA 510(k) clearance (K121470), as well as MDD and MDR compliance, confirming it meets regulatory standards for accuracy and safety in blood pressure monitoring. This classification ensures it adheres to strict guidelines for cardiovascular diagnostic devices, though it does not specify MRI safety or sterility requirements.