Upper Arm Electronic Blood Pressure Monitor
by Conmo Electronic Company Limited
510(k) K202372
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK202372 | Date30 Dec 2020 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Upper Arm Electronic Blood Pressure Monitor is a non‑invasive device that measures arterial blood pressure at the upper arm using electronic sensors. It provides systolic and diastolic pressure readings to assist healthcare professionals in assessing cardiovascular status.
The device was cleared through the FDA 510(k) pathway (K202372) as a substantially equivalent, traditional clearance under product code DXN. The submission was reviewed by the Cardiovascular advisory committee and received clearance on 30 December 2020. It is manufactured by Conmo Electronic Company Limited in Shenzhen, China.
Other devices from Conmo Electronic Company Limited
Questions
AI-generated answers, 6 Oct 2026
What clinical measurements does this monitor provide?
It delivers both systolic and diastolic arterial pressure values by detecting pressure changes at the upper arm with electronic sensors, allowing clinicians to evaluate a patient’s cardiovascular status.
How is the device supplied and is it sterile?
The monitor is supplied as a complete, non‑sterile unit ready for clinical use. Because it is non‑invasive and contacts the skin only with a cuff, sterility is not required for its intended application.
Is the monitor intended for single‑use or repeated use?
It is designed for repeated use in a healthcare setting. The cuff can be cleaned according to standard infection‑control procedures, and the electronic unit is built for durable, ongoing operation.
What regulatory pathway was used for clearance?
The device received traditional FDA 510(k) clearance (K202372) as substantially equivalent to a predicate device, with review by the Cardiovascular advisory committee and clearance dated 30 December 2020.