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Cardimax Fx-406U

by Brentwood Instruments, Inc. 510(k)

Active United States

510(k) K854505

Overview

This device is a transducer, blood-pressure, extravascular, used for diagnostic ultrasound imaging. It is classified as a Class II medical device under FDA regulation 870.2850.

The CARDIMAX FX-406U was cleared via the traditional 510(k) pathway (K854505) on February 4, 1986, and is manufactured by Brentwood Instruments, Inc. It is intended for use in cardiovascular applications and is supplied as a non-sterile, reusable device for clinical settings.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK854505 Date4 Feb 1986ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
DRS
Device Class
Class II
Regulation
21 CFR Part 870.2850
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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