Takeda Medical Digital Sphygmomanometer/ UA-741
510(k) K872629
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872629 | Date15 Sep 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 24 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- Withdrawn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, 19 Sep 2026
The Takeda Medical Digital Sphygmomanometer/ UA-741 is a digital blood pressure measuring device classified under product code DXN. It is a substantially equivalent device cleared through the FDA 510(k) process.
It was cleared by the FDA on September 15, 1987, under K872629, and is manufactured by A&D Engineering, Inc. The device is intended for use in cardiovascular-related applications as indicated by the advisory committee classification.
Other devices from A&D Engineering, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the Takeda Medical Digital Sphygmomanometer/ UA-741 intended for?
The device is intended for use in cardiovascular-related applications, as indicated by its advisory committee classification under product code DXN, which reflects its classification for blood pressure measurement in cardiovascular monitoring contexts.
How was the Takeda Medical Digital Sphygmomanometer/ UA-741 cleared for market entry?
The device was cleared through the FDA 510(k) process as a substantially equivalent device, meaning it demonstrated safety and effectiveness by comparison to a legally marketed predicate device, without requiring premarket approval.
When did the FDA clear the Takeda Medical Digital Sphygmomanometer/ UA-741?
The device received FDA clearance on September 15, 1987, under the 510(k) number K872629, as documented in the device's authorization and decision records.
Who manufactures the Takeda Medical Digital Sphygmomanometer/ UA-741?
The device is manufactured by A&D Engineering, Inc., which is listed as the applicant and manufacturer in the device's authorization data, with their address located in San Jose, California.
What product code classifies the Takeda Medical Digital Sphygmomanometer/ UA-741?
The device is classified under product code DXN, which is used by the FDA to categorize devices based on their intended use and technology, in this case corresponding to digital sphygmomanometers for blood pressure measurement.