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AutoPulse Model 100

by Revivant Corp.

510(k) K011046

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 · Traditional NumberK011046 Date25 Oct 2001ClearedStatusActive

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  • Withdrawn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, 1 Oct 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 Model 100 is an External Cardiac Compressor, designed to assist in cardiopulmonary resuscitation (CPR) by mechanically delivering controlled chest compressions. It is classified as a Class II device under the FDA’s regulatory framework and is intended for use in emergency resuscitation scenarios to improve blood flow and oxygenation during cardiac arrest. The device operates as an adjunct to manual CPR, providing consistent compression depth and rate to enhance patient outcomes.

Supplied as a reusable medical device, the AutoPulse Model 100 is intended for use in clinical settings such as emergency departments, pre-hospital environments, and critical care units. It requires compatible battery packs (not included) for operation and is regulated under FDA 510(k) clearance (K011046) with a traditional review pathway. The system is designed for single-patient use per session, with maintenance and cleaning protocols specified in its user manual. No MRI safety information is provided in the available data.

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