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Autopulse Resuscitation System

by Revivant Corp.

510(k) K022345

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK022345 Date15 Aug 2002ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2090-2014 FDA Class III initiated 16 Jul 2013

    Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. The label is specific to the Japanese version of the product.

    • Terminated Z-0658-2013 FDA Class II initiated 8 Aug 2012

    Complaints associated with an unexpected stop in AutoPulse compressions.

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  • Withdrawn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
DRM
Device Class
Class II
Regulation
21 CFR Part 870.5200
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 AutoPulse Resuscitation System Model 100 is an external cardiac compressor designed to deliver controlled, high-quality chest compressions during cardiopulmonary resuscitation (CPR). Classified as a Class II device under FDA regulations, it is intended to assist in maintaining circulation when manual CPR is impractical or insufficient, particularly in emergency settings where sustained, consistent compression is critical.

This system is supplied as a reusable medical device, intended for use in pre-hospital, emergency department, and critical care environments. It operates with Revivant Corp.-approved accessories and requires no additional battery (as noted in the manual context), though storage and maintenance follow manufacturer guidelines to ensure proper functionality. The device is regulated under FDA 510(k) clearance (K022345) and adheres to compliance standards for external cardiac compressors, including MRI safety considerations where applicable.

Other devices from Revivant 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 environments is the AutoPulse Resuscitation System designed for, and how does its reusable nature impact its use?

    The AutoPulse Resuscitation System is specifically designed for pre-hospital settings, emergency departments, and critical care environments where sustained, consistent chest compressions are critical during CPR. Since it is a reusable device, it requires strict adherence to Revivant Corp.’s storage and maintenance guidelines to ensure reliability and functionality over repeated uses. This makes it ideal for high-traffic or long-term clinical settings where single-use alternatives may not be practical.

  • Does the AutoPulse Resuscitation System require any additional power source, and if not, how is it powered?

    The AutoPulse Resuscitation System does not require an additional battery, as noted in its manual context. Instead, it operates using its own integrated power source, which is designed to deliver consistent compressions during CPR. However, proper storage and maintenance are essential to ensure the device remains operational for emergency use.

  • What regulatory pathway was followed for the FDA clearance of the AutoPulse Resuscitation System, and what does this mean for its use?

    The AutoPulse Resuscitation System was cleared through the FDA’s 510(k) pathway, specifically under clearance number K022345, with a decision date of August 15, 2002. This classification as a Class II device and the special 510(k) clearance route indicate that it has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets FDA standards for external cardiac compressors while adhering to compliance requirements, including MRI safety considerations where applicable.

  • Are there multiple models or sizes available for the AutoPulse Resuscitation System, and how would a buyer determine the correct fit for their needs?

    The provided data does not specify multiple models or sizes for the AutoPulse Resuscitation System, but it is classified under product code DRM (Defibrillator/Resuscitator Modules) and is intended for general use in cardiac resuscitation. Buyers should consult Revivant Corp.’s technical specifications or contact their support team to confirm compatibility with their specific clinical or pre-hospital requirements, such as patient size ranges or environmental conditions.