Copal Digital Sphygmomamometer Ua-550
by Takeda Medical, Inc. 510(k)
Active
510(k) K844285
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844285 | Date18 Apr 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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, 23 Sep 2026
The Copal Digital Sphygmomanometer UA-550 is a digital device designed for measuring blood pressure. It functions as an electronic sphygmomanometer to provide cardiovascular monitoring readings.
This device is manufactured by Takeda Medical, Inc. and has received FDA 510(k) clearance under K844285. It is categorized under product code DXN for cardiovascular applications.
Other devices from Takeda Medical, Inc.
Questions
AI-generated answers, 23 Sep 2026
What is the primary function of the Copal UA-550?
The Copal UA-550 is an electronic, digital sphygmomanometer designed specifically for measuring blood pressure to assist in cardiovascular monitoring.
Has this device undergone regulatory review?
Yes, the Copal Digital Sphygmomanometer UA-550 has received FDA 510(k) clearance under K844285, confirming it is substantially equivalent to other devices in the cardiovascular product category.
Who is the manufacturer of the UA-550?
This device is manufactured by Takeda Medical, Inc., located in Irvine, California.