510(k) Report

FDA applicant

Vacumed, Div. of Vacumetrics, Inc.

Salt Lake City, UT2 decisions1998–19980 recalls

FDA records 2 decisions for Vacumed, Div. of Vacumetrics, Inc. (Salt Lake City, UT) in 1998: 2 510(k) clearances. Most are in product codes CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) and CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). 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, anesthesiology panel, where it files most

How often FDA has decided Vacumed, Div. of Vacumetrics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vacumed, Div. of Vacumetrics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vacumed, Div. of Vacumetrics, 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?

  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase1decision
  • CCLAnalyzer, Gas, Oxygen, Gaseous-Phase1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K973544Vacu*Med, Gold Edition Carbon Dioxide Gas AnalyzerVacumed, Div. of Vacumetrics, Inc. · 1998
  • K973545Vacu*Med Gold Edition Oxygen Gas AnalyzerVacumed, Div. of Vacumetrics, Inc. · 1998

All 2 as Vacumed, Div. of Vacumetrics, Inc. →