510(k) Report

FDA applicant

Vivometrics, Inc.

Washington, DC3 decisions2002–20050 recalls

FDA records 3 decisions for Vivometrics, Inc. (Washington, DC) from 2002 to 2005: 3 510(k) clearances. All are in product code DQK (Computer, Diagnostic, Programmable). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is 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 Vivometrics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vivometrics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • DQKComputer, Diagnostic, Programmable3decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 0 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.

  • K043604Lifeshirt Real-Time with Vivomonitor SoftwareVivometrics, Inc. · 20055cite it
  • K011903Lifeshirt System with Vivologic Analysis SoftwareVivometrics, Inc. · 20023cite it

What has FDA decided for it lately?

  • K043604Lifeshirt Real-Time with Vivomonitor SoftwareVivometrics, Inc. · 2005
  • K031550Reusable Multiple-Patient Lifeshirt with Vivologic Analysis SoftwareVivometrics, Inc. · 2003
  • K011903Lifeshirt System with Vivologic Analysis SoftwareVivometrics, Inc. · 2002

All 3 as Vivometrics, Inc. →