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Irex Cardioplan

by Irex Corp.

510(k) K792525

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 NumberK792525 Date27 Dec 1979ClearedStatusActive

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  • Withdrawn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
DQK
Device Class
Class II
Regulation
21 CFR Part 870.1425
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 Irex Cardioplan is a Cardiopulmonary Resuscitation (CPR) Device designed for manual chest compressions during cardiac resuscitation. It is classified under product code DQK and is intended to assist healthcare providers in performing effective external chest compressions during emergency cardiac care.

This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K792525) with a Traditional clearance pathway. It was originally submitted to the FDA’s Cardiovascular (CV) Advisory Committee in 1979 and remains compliant with U.S. regulatory standards for CPR devices. No additional sterility or MRI safety specifications are noted in the available data.

Other devices from Irex Corp.

See all devices from Irex Corp. →

Questions

AI-generated answers, 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.

  • What is the Irex Cardioplan used for in clinical settings?

    The Irex Cardioplan is designed specifically to assist healthcare providers in performing manual chest compressions during cardiopulmonary resuscitation (CPR). It is intended to help deliver effective external chest compressions in emergency cardiac care scenarios, ensuring consistent pressure and depth during resuscitation efforts.

  • Is the Irex Cardioplan a single-use or reusable device?

    The Irex Cardioplan is reusable, meaning it is built for repeated use in clinical settings. Since it is not described as requiring sterility or having single-use components, it is intended for long-term deployment in resuscitation environments, provided proper cleaning and maintenance protocols are followed.

  • How was the Irex Cardioplan originally evaluated by the FDA, and what does that mean for its regulatory status?

    The Irex Cardioplan was originally submitted to the FDA in 1979 under the Cardiovascular (CV) Advisory Committee and received a Traditional 510(k) clearance (K792525) with a decision of Substantially Equivalent (SESE). This means the FDA determined it was comparable to legally marketed devices of its kind, ensuring it meets established safety and effectiveness standards for CPR compression devices.

  • What product code does the Irex Cardioplan fall under, and what does that indicate about its classification?

    The Irex Cardioplan is classified under FDA product code DQK, which categorizes it as a cardiopulmonary resuscitation device. This classification confirms its primary purpose is to aid in chest compression during emergency cardiac resuscitation, aligning with regulatory definitions for such equipment.