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Autopulse Resuscitation System Model 100 Modification

by Revivant Corp.

510(k) K032852

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 NumberK032852 Date12 Nov 2003ClearedStatusActive

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  • Withdrawn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)

Full name
Modification to: Autopulse Resuscitation System Model 100
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, 21 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 Modification is an external cardiac compressor designed to deliver automated chest compressions during cardiopulmonary resuscitation. It functions as a mechanical device that provides consistent compressive force to support circulation in patients requiring resuscitation.

This modification is submitted to the FDA under a 510(k) clearance (K032852) as a Class II device and is deemed substantially equivalent to the predicate Autopulse system. It is supplied as a modification to the existing Autopulse Resuscitation System, identified by the model number 100, and is regulated under the cardiovascular advisory committee.

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