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System 7500 NIBP/SA02

by Advanced Medical Instruments, Inc.

510(k) K924910

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 NumberK924910 Date13 May 1993ClearedStatusActive

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  • Withdrawn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, 19 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 System 7500 NIBP/SA02 is a non-invasive blood pressure (NIBP) and pulse oximetry (SpO₂) monitoring device. It measures and displays blood pressure and oxygen saturation levels, providing critical hemodynamic data for patient assessment in clinical settings.

This device is intended for single-use or reusable applications in hospital, clinic, or home environments, depending on the cuff and sensor configuration. It operates as a Class II medical device under FDA 510(k) clearance (K924910) and adheres to standard sterility and safety protocols for patient monitoring. The device is supplied with appropriate cuff sizes and sensors, and its use is governed by regulatory compliance with the FDA’s traditional 510(k) review process.

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