510(k) Report

FDA applicant

Vita-Stat

Mchenry, IL3 decisions1981–19890 recalls

FDA records 3 decisions for Vita-Stat (Mchenry, IL) from 1981 to 1989: 3 510(k) clearances. Most are in product codes DSK (Computer, Blood-Pressure) and BZL (Computer, Oxygen-Uptake). 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 Vita-Stat’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vita-Stat since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vita-Stat 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?

  • DSKComputer, Blood-Pressure2decisions
  • BZLComputer, Oxygen-Uptake1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K811146Vita-Stat Model 8000-CVita-Stat · 19811cites it

What has FDA decided for it lately?

  • K895586VVR/Q CalorimeterVita-Stat · 1989
  • K811146Vita-Stat Model 8000-CVita-Stat · 1981
  • K811147Vita-Stat Model 9000-aVita-Stat · 1981

All 3 as Vita-Stat →

Other applicant names beginning “Vita-Stat”

FDA records each applicant name separately; these may or may not be the same firm.

Vita Zahnfabrik H.Rauter GmbH & Co. 13Vita-Stat Medical Services, Inc. 5Vita 1Vita Zanhnfabrik H. Rauter GmbH Co. 1Vita-Course Technologies Co., Ltd. 1Vita-Tan Corp. 1Vita Medics 1Vita Dental Co. 1