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Autopulse Resuscitation System, Model 100

by Revivant Corp.

510(k) K040453

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK040453 Date11 Mar 2004ClearedStatusActive

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  • Withdrawn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

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