Blood Pressure Kit, Well-Be 669

by Pearlduck, Inc.

510(k) K761274

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K761274↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK761274	Date5 Jan 1977Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K761274
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, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Blood Pressure Kit, Well-Be 669 is a non-invasive blood pressure measurement system designed to measure arterial blood pressure indirectly through the application of a cuff around the upper arm. It comprises components such as a sphygmomanometer, stethoscope, and cuff assembly to facilitate auscultatory measurement of systolic and diastolic pressure. This device falls under the classification of a system for measuring blood pressure and is intended for clinical or home use to assess cardiovascular health parameters. Its design aligns with traditional mercury-free manual blood pressure monitoring standards.

This kit is supplied as a reusable system, including a folding stethoscope, inflatable cuff, and a carrying case for transport and storage. The device is not sterile and is intended for single-user or shared clinical settings where hygiene protocols are followed. No specific MRI safety information is provided, and the device operates under FDA 510(k) clearance (K761274) as substantially equivalent to predicate devices. Storage should be in a clean, dry environment to preserve functionality, and the components must be inspected periodically for wear or damage.