Takeda Medical Digital Sphygmomanometer UA-731
510(k) K854797
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854797 | Date9 May 1986 | 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- Withdrawn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, 1 Oct 2026
The Takeda Medical Digital Sphygmomanometer UA-731 is an automated blood pressure measurement device designed to measure systolic and diastolic blood pressure. Classified under product code DXN, this device is intended for clinical use in assessing cardiovascular health by providing accurate readings of arterial pressure. Its digital display facilitates precise measurement and recording, reducing human error associated with manual sphygmomanometers. The device operates on the principle of oscillometry, a non-invasive method for blood pressure assessment.
The UA-731 is supplied as a reusable medical device and is intended for use in clinical settings such as hospitals, physician offices, and diagnostic laboratories. It requires calibration and maintenance as specified by the manufacturer to ensure accuracy and reliability. The device holds an FDA 510(k) clearance under K854797, classified as substantially equivalent to legally marketed predicates, and was reviewed by the Cardiovascular (CV) Advisory Committee. No specific sterility or MRI safety information is provided in the available data, and storage conditions should follow manufacturer guidelines to preserve functionality.
Other devices from Takeda Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Takeda UA-731 Digital Sphygmomanometer used for?
The UA-731 is designed for clinical assessment of cardiovascular health by measuring systolic and diastolic blood pressure. It uses oscillometry—a non-invasive method—to provide accurate arterial pressure readings, helping clinicians monitor patients in settings like hospitals, physician offices, or diagnostic labs.
Is the UA-731 a single-use or reusable device?
The UA-731 is a reusable medical device. It is intended for repeated use in clinical environments, provided it undergoes regular calibration and maintenance as outlined by the manufacturer to ensure continued accuracy and reliability.
How does the UA-731 differ from manual sphygmomanometers?
Unlike manual devices, the UA-731 automates blood pressure measurement using oscillometry, eliminating human error in reading cuff inflation/deflation. Its digital display provides immediate, precise systolic/diastolic readings, improving efficiency and consistency in clinical assessments.
What storage conditions should be followed for the UA-731?
While specific storage guidelines aren’t detailed in the provided data, the device’s functionality depends on adherence to manufacturer-recommended conditions. This typically includes protection from extreme temperatures, moisture, and physical damage to preserve calibration and performance.
Does the UA-731 require any special handling for sterility?
The available data does not specify sterility requirements or procedures for the UA-731. Since it is reusable, clinical settings should follow standard infection control protocols (e.g., cleaning between uses) to maintain hygiene and prevent cross-contamination.