510(k) Report

FDA applicant

Revivant Corp.

Sunnyvale, CA4 decisions2001–20042 recalls

FDA records 4 decisions for Revivant Corp. (Sunnyvale, CA) from 2001 to 2004: 4 510(k) clearances. All are in product code DRM (Compressor, Cardiac, External). Its devices cite 9 predicates, 6 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Revivant Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Revivant Corp. since 2007.

Recalls per year

1in 2013

2012: 12013: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Revivant Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Revivant Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DRMCompressor, Cardiac, External4decisions

Whose devices does it build on?

Its devices cite 9 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K040453Autopulse Resuscitation System, Model 100Revivant Corp. · 20044cite it
  • K011046Autopulse, Model 100Revivant Corp. · 20014cite it
  • K022345Autopulse Resuscitation SystemRevivant Corp. · 20023cite it
  • K032852Modification to: Autopulse Resuscitation System Model 100Revivant Corp. · 20032cite it

What has FDA decided for it lately?

  • K040453Autopulse Resuscitation System, Model 100Revivant Corp. · 20042 recalls
  • K032852Modification to: Autopulse Resuscitation System Model 100Revivant Corp. · 20032 recalls
  • K022345Autopulse Resuscitation SystemRevivant Corp. · 20022 recalls
  • K011046Autopulse, Model 100Revivant Corp. · 20012 recalls

All 4 as Revivant Corp. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K011046Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH)…Jul 16, 2013Class III
  • K011046AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The…Aug 8, 2012Class II