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Blood Pressure Meter Model No. BPM888

by Integrated Display Technology, Ltd.

510(k) K941490

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

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK941490 Date29 Nov 1994ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

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 Meter Model No. BPM888 is a blood pressure measurement device designed to assess systolic and diastolic values. It operates as a digital monitoring instrument for clinical or home use, providing quantitative readings of arterial pressure.

The device is supplied by Integrated Display Technology, Ltd. and is classified under FDA product code DXN. It received FDA 510(k) clearance under K941490 with a substantially equivalent decision. The device is intended for use in cardiovascular monitoring settings and falls under the Cardiovascular review advisory committee. It is a single-use or reusable device as indicated by its model specifications, though specific sterility and MRI safety details are not provided in the available data.

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