Skip to content

Pollenex Digital Sphygmomanometer BP-4000

by Associated Mills, Inc. 510(k)

Active United States

510(k) K844397

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK844397 Date18 Apr 1985ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DSK
Device Class
Class II
Regulation
21 CFR Part 870.1110
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 Pollenex Digital Sphygmomanometer BP-4000 is a digital blood-pressure measurement device designed to accurately monitor systolic and diastolic blood pressure. As a computer-based sphygmomanometer, it automates cuff inflation and deflation, providing precise readings for clinical or home use. Its classification aligns with FDA’s definition of a blood-pressure measuring instrument, intended for cardiovascular assessment.

This device is supplied as a reusable medical instrument, intended for use in clinical settings such as hospitals, physician offices, or patient homes. It requires no sterilization as it is not single-use, but proper cleaning and maintenance are essential to ensure accuracy and hygiene. The Pollenex Digital Sphygmomanometer BP-4000 holds an FDA 510(k) clearance (K844397) under the traditional review pathway, classified as a Class II device under regulation 870.1110. No MRI safety or sterility specifications are noted in the regulatory data.

Other devices from Associated Mills, Inc.

See all devices from Associated Mills, Inc. →