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Digital Sphygmomanometer UA-701

by A&D Engineering, Inc. 510(k)

Active United States

510(k) K870728

Overview

The Digital Sphygmomanometer UA-701 is a blood pressure measurement device designed to accurately monitor systolic and diastolic blood pressure. Classified as an amplifier and signal conditioner for transducer signals, it converts mechanical pressure readings into digital values for precise cardiovascular assessment. This device is intended for clinical and home use to aid in the diagnosis and management of hypertension and other cardiovascular conditions.

The UA-701 is supplied as a reusable electronic device with a cuff for arm measurements, requiring calibration and periodic maintenance. It operates in non-sterile environments and is not intended for MRI use. The device holds an FDA 510(k) clearance under classification DRQ (Device Regulation Number 870.2060) and was reviewed by the Cardiovascular Advisory Committee. Storage should follow manufacturer guidelines to ensure accuracy and longevity.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK870728 Date27 Mar 1987ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

510(k)

Full name
Takeda Medical Digital Sphygmomanometer Ua-701
510(k) Number
FDA Product Code
DRQ
Device Class
Class II
Regulation
21 CFR Part 870.2060
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the UA-701 Digital Sphygmomanometer used for?

    The UA-701 is designed to measure systolic and diastolic blood pressure accurately, supporting the diagnosis and management of hypertension and other cardiovascular conditions. It converts mechanical pressure readings into digital values, making it suitable for both clinical and home use.

  • Is the UA-701 Digital Sphygmomanometer reusable or single-use?

    The UA-701 is a reusable electronic device. It requires periodic calibration and maintenance to ensure continued accuracy, as outlined in the manufacturer’s guidelines. The cuff included for arm measurements is also reusable.

  • What type of environment is the UA-701 intended for?

    The UA-701 is intended for use in non-sterile environments only. It is not designed for sterile procedures or MRI-compatible settings, so care must be taken to avoid exposure to magnetic fields.

  • How should the UA-701 Digital Sphygmomanometer be stored?

    To maintain accuracy and longevity, the UA-701 should be stored according to the manufacturer’s guidelines. This typically includes keeping it in a clean, dry place away from direct sunlight, extreme temperatures, and sources of electromagnetic interference.

  • What regulatory clearance does the UA-701 hold?

    The UA-701 holds FDA 510(k) clearance under classification DRQ (Device Regulation Number 870.2060). It was reviewed by the Cardiovascular Advisory Committee and classified as substantially equivalent to predicate devices.