510(k) Report

FDA applicant

Ceramatec, Inc.

Salt Lake City, UT4 decisions1988–19980 recalls

FDA records 4 decisions for Ceramatec, Inc. (Salt Lake City, UT) from 1988 to 1998: 4 510(k) clearances. All are in product code 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 Ceramatec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ceramatec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ceramatec, 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?

  • CCLAnalyzer, Gas, Oxygen, Gaseous-Phase4decisions

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 7 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.

  • K973282Handi Oxygen AnalyzerCeramatec, Inc. · 19983cite it
  • K972992Ceramatec Maxcell and Cag Galvanic Oxygen SensorsCeramatec, Inc. · 19982cite it
  • K911344Cerion Hand Held Oxygen AnalyzerCeramatec, Inc. · 19912cite it

What has FDA decided for it lately?

  • K972992Ceramatec Maxcell and Cag Galvanic Oxygen SensorsCeramatec, Inc. · 1998
  • K973282Handi Oxygen AnalyzerCeramatec, Inc. · 1998
  • K911344Cerion Hand Held Oxygen AnalyzerCeramatec, Inc. · 1991
  • K880448Cerion Oxy Threshold AlarmCeramatec, Inc. · 1988

All 4 as Ceramatec, Inc. →