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Non-Invasive Blood Pressure (NIBP) Monitor (Model 90553)

by Spacelabs Medical, Inc.

510(k) K941167

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 NumberK941167 Date14 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  • Withdrawn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, 1 Oct 2026

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

The Non-Invasive Blood Pressure (NIBP) Monitor (Model 90553) is a medical device classified as a blood pressure monitor, designed to measure systolic, diastolic, and mean arterial pressure without penetrating the skin. It employs transducers placed on the body surface to derive pressure readings, enabling continuous or intermittent assessment of cardiovascular function. This device is intended for clinical and ambulatory use to support diagnostic and monitoring purposes in various healthcare settings. Its design adheres to regulatory standards for non-invasive blood pressure measurement systems.

This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K941167) with a traditional review pathway, classified under product code DXN. It is intended for use in clinical environments, including cardiology and remote monitoring settings, where accurate blood pressure assessment is required. The monitor is not specified as MRI-safe or sterile upon packaging, and its operational specifications are detailed in the FDA submission for substantial equivalence. No additional sterility or single-use claims are provided in the regulatory data.

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